Carpal Tunnel SyndromePhase 4NOR-CACTUSNCT05306548
A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome
A Phase 4 study testing Surgical carpal tunnel release and Injection, Triamcinolone Hexacetonide, Per 5 Mg in people with Carpal Tunnel Syndrome, run by Diakonhjemmet Hospital at 5 sites in Norway.
Trial summary
Carpal tunnel syndrome (CTS) causes numbness and pain in the hand and arm, and is an important cause of work absence and disability. The aim of the NOR-CACTUS Trial is to compare outcomes of a treatment strategy where the initial treatment is up to two ultrasound-guided corticosteroid injections, followed by scheduled… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Surgical carpal tunnel release and Injection, Triamcinolone Hexacetonide, Per 5 Mg
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 5 sitesNorway
- Study dates
- 8 Apr 2022to Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years of age)
- Patient history indicating CTS
- Neurophysiological examination performed within 6 months
- Diagnosis of CTS based on:
- Classic/probable or possible symptoms, and neurophysiological findings consistent with CTS
- Or, in case of normal neurophysiological findings:
- Classic/probable symptoms and positive physical exam findings and/or nighttime symptoms
- Mild to moderate symptoms (intermittent, interfering with everyday life, and/or disturb sleep)
Who cannot join
- Previous CTS surgery or corticosteroid injection in the carpal tunnel in the relevant hand
- Diagnosis of severe CTS, based on history and examination indicating severe CTS with constant symptoms including pain, loss of sensibility, dexterity or reduced temperature sensation, weakness of thumb abduction and opposition, or atrophy of thenar musculature. Disappearance of pain may indicate permanent sensory loss.
- History suggesting underlying causes of CTS e.g. inflammatory wrist arthritis and/or flexor tenosynovitis
- Previous significant trauma or fracture, deformity or tumor in the wrist or hand in the relevant hand
- Presence of conditions affecting a normal nerve function e.g. cervical disc herniation, polyneuropathy or previous nerve injury
- Major co-morbidities, such as severe malignancies, severe or uncontrolled infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV) and/or severe respiratory diseases, severe renal failure, active ulcus ventriculi, leukopenia and/or thrombocytopenia
Show all 16Show fewer
- Severe psychiatric or mental disorders
- Local infection or wound in the affected hand/wrist
- Any other medical condition that according to the treating physician and/or local guidelines makes adherence to treatment protocol impossible
- Inadequate birth control1, pregnancy2, and/or breastfeeding (current at screening or planned within the duration of the study)
- Known hypersensitivity to Triamcinolone Hexacetonide (Lederspan) or any of the excipients (sorbitol, polysorbate or benzyl alcohol)
- Concomitant therapy with CYP3A-inhibitors or digitalis glycosides
- Patients vaccinated or immunized with live virus vaccines within 2 weeks of treatment
- Alcohol or other substance abuse
- Language barriers
- Other factors which make adherence to study protocol impossible
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Akershus University Hospital
Lørenskog, Akershus, 1461
Department of Surgery and Anesthesiology, Diakonhjemmet Hospital
Oslo, Norge, 1450
Department of Rheumatology, Diakonhjemmet Hospital
Oslo, 0319
Department of Orthopedic Surgery, Martina Hansens Hospital
Sandvika
Department of Rheumatology, Martina Hansens Hospital
Sandvika
About this study
Official title: The NOR-CACTUS Trial - A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) causes numbness and pain in the hand and arm, and is an important cause of work absence and disability. The aim of the NOR-CACTUS Trial is to compare outcomes of a treatment strategy where the initial treatment is up to two ultrasound-guided corticosteroid injections, followed by scheduled clinical assessment of treatment effect, and subsequent surgery if needed, to a treatment strategy where surgery is the first-line treatment. Participants will be randomized to one of the treatment strategies, and followed up for two years after start of the study intervention. Outcomes will include patient-reported, clinical, functional and neurophysiological measures, and health-economic aspects. The hypothesis of the study is that there is no difference between the two treatment groups in the percentage of patients with a satisfactory symptom relief (treatment success) one year after the initial therapeutic intervention.
Read the detailed description
CTS is the most common non-traumatic hand disorder, prevalent in approximately 4% of the adult population. The condition may have a substantial impact on an individual's quality of life, ability to accomplish activities of daily living, and to perform occupational duties. Associated healthcare costs represent a significant socioeconomic burden.
Currently, many patients with mild and moderate CTS treated surgically without a preceding trial of less invasive non-surgical therapies. An increase in the use of non-surgical first-line therapies (e.g. corticosteroid injection into the carpal tunnel), while reserving surgery for refractory cases, aim to optimize the trade-off between treatment risk and benefit, while also ensuring appropriate use of health resources. However, there is a lack of studies directly comparing the efficacy of corticosteroid injections to surgery, and the long-term safety of corticosteroid injections has not been investigated.
It is not well-known if patients who are initially treated with corticosteroid injections will eventually need to proceed to surgery, and therefore may have to endure the symptoms for a longer period of time, with potentially worse long-term outcomes, compared to patients who has surgery as first-line treatment. On the other hand, it is not beneficial if patients are unnecessarily exposed to the risks associated with surgery, if symptoms could have been satisfactory resolved with a non-surgical method.
The current study will assess if first-line treatment with up to two ultrasound-guided corticosteroid injections is non-inferior to surgery with regards to treatment success. A less invasive treatment approach might result in important benefits to the patient, e.g. less pain, reduced risk of complications, and faster return to work and activities. This might also be of importance to family members, as many CTS patients are at an age where they have care responsibilities. Non-surgical treatments might benefit society by decreasing work absence and reducing health expenditure, and allowing better access to surgical services for other patient groups. High quality documentation is needed to provide a base for future treatment guidelines. Evidence based clinical guidelines provide treatment decision support and help reduce national and regional differences in treatment practices, and ensure that all patients have equal access to evidence-based treatment.
In the NOR-CACTUS trial, adult individuals with idiopathic CTS of a mild-to-moderate degree will be randomized to receive either A) Primary open surgical carpal tunnel release, or B) Up to two ultrasound-guided corticosteroid (triamcinolone hexacetonide) injections in the carpal tunnel, and subsequent open surgical carpal tunnel release in case of unsatisfactory treatment result. Participants will be randomized to receive one of the treatment strategies, and followed for two years, with the primary endpoint being successful treatment result one year after start of the intervention.
The hypothesis of the study is that the percentage of patients with a satisfactory symptom relief (treatment success) one year after the initial therapeutic intervention in the injection treatment strategy arm is non-inferior to that of the surgery treatment arm. The primary outcome is based on the disease-specific patient-reported outcome Boston Carpal Tunnel Questionnaire (BCTQ) symptom severity scale (SSS). Further outcomes will include other patient-reported, clinical, functional and neurophysiological measures, and health-economic aspects.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Surgical carpal tunnel release, Injection, Triamcinolone Hexacetonide, Per 5 Mg
- Keywords
- Surgery, Corticosteroid injection, Ultrasound guided intervention, Nerve conduction studies, Randomized controlled trial
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical carpal tunnel releaseProcedure or surgery
Also called Open surgical carpal tunnel release
Open surgical division of the flexor retinaculum of the palm/wrist to release pressure on the median nerve
Injection, Triamcinolone Hexacetonide, Per 5 MgDrug
Also called Ultrasound-guided corticosteroid injection
Ultrasound-guided injection of 20 mg of triamcinolone hexacetonide (or -acetonide) into the carpal tunnel space close to the median nerve
| Study group | Role | What they receive |
|---|---|---|
| Surgery treatment strategy | Active comparator | Primary open surgical carpal tunnel release. Treatment effect is monitored on scheduled follow-up visits. Re-operation may be performed if medically indicated (e.g. postoperative complication, or failure of the primary procedure) Receives: Procedure: Surgical carpal tunnel release |
| Injection treatment strategy | Experimental | Primary treatment with ultrasound-guided corticosteroid injection. Treatment effect is monitored on scheduled follow-up visits. One additional injection may be administered, and subsequently surgical carpal tunnel release is performed in case of unsatisfactory treatment effect of the injection therapy. Treatment effect is graded on a 5-leve scale by subject from 1 (complete improvement) to 5 (severe worsening) of symptoms. Incomplete improvement (score 2 or higher) results in a second injection or secondary surgery. Receives: Procedure: Surgical carpal tunnel release; Drug: Injection, Triamcinolone Hexacetonide, Per 5 Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful treatment result after 12 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5 after 12 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5. The primary outcome measure is achievement of BCTQ SSS ≤ 1.5, interpreted as a successful treatment result, 12 months after start of the study intervention.
Measured: 12 months
Secondary outcomes (44)
Successful treatment result after 3 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5 after 3 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5. The outcome measure is achievement of BCTQ SSS ≤ 1.5, interpreted as a successful treatment result, 3 months after start of the study intervention.
Measured: 3 months
Successful treatment result after 6 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5 after 6 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5. The outcome measure is achievement of BCTQ SSS ≤ 1.5, interpreted as a successful treatment result, 6 months after start of the study intervention.
Measured: 6 months
Successful treatment result after 24 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5 after 24 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5. The outcome measure is achievement of BCTQ SSS ≤ 1.5, interpreted as a successful treatment result, 24 months after start of the study intervention.
Measured: 24 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (range 1-5)
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5, used as outcome measure.
Measured: 0-24 months
Boston Carpal Tunnel Questionnaire Functional Status Scale
Boston Carpal Tunnel Questionnaire Functional Status Scale (range 1-5)
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related functional impairment. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5, used as outcome measure.
Measured: 0-24 months
Nerve conduction studies: Motor median nerve distal latency
Nerve conduction studies of motor median nerve distal latency (milliseconds)
Measurement points:
- Distal: at the wrist, 8 cm proximal to the m. abductor pollicis brevis.
- Proximal: at the cubital fossa
Measured: 0 and 12 months
Nerve conduction studies: Motor median nerve proximal latency
Nerve conduction studies of motor median nerve proximal latency (milliseconds)
Median nerve measurement points:
- Distal: at the wrist, 8 cm proximal to the m. abductor pollicis brevis.
- Proximal: at the cubital fossa
Measured: 0 and 12 months
Nerve conduction studies: Motor median nerve amplitude
Nerve conduction studies of motor median nerve amplitude (millivolts)
Median nerve measurement points:
- Distal: at the wrist, 8 cm proximal to the m. abductor pollicis brevis.
- Proximal: at the cubital fossa
Measured: 0 and 12 months
Nerve conduction studies: Motor median nerve conduction velocity
Nerve conduction studies of motor median nerve amplitude conduction velocity (meters per second)
Median nerve measurement points:
- Distal: at the wrist, 8 cm proximal to the m. abductor pollicis brevis.
- Proximal: at the cubital fossa
Measured: 0 and 12 months
Nerve conduction studies: Motor ulnar nerve distal latency
Nerve conduction studies of motor ulnar nerve distal latency (milliseconds)
Ulnar nerve measurement points:
- Distal: at the wrist, 8 cm proximal to the abductor digiti minimi
- Proximal: 3 cm distal to the medial epicondyle of the elbow
Measured: 0 and 12 months
Nerve conduction studies: Motor ulnar nerve proximal latency
Nerve conduction studies of motor ulnar nerve proximal latency (milliseconds)
Ulnar nerve measurement points:
- Distal: at the wrist, 8 cm proximal to the abductor digiti minimi
- Proximal: 3 cm distal to the medial epicondyle of the elbow
Measured: 0 and 12 months
Nerve conduction studies: Motor ulnar nerve amplitude
Nerve conduction studies of motor ulnar nerve amplitude (millivolts)
Ulnar nerve measurement points:
- Distal: at the wrist, 8 cm proximal to the abductor digiti minimi
- Proximal: 3 cm distal to the medial epicondyle of the elbow
Measured: 0 and 12 months
Nerve conduction studies: Motor ulnar nerve conduction velocity
Nerve conduction studies of motor ulnar nerve conduction velocity (meters per second)
Ulnar nerve measurement points:
- Distal: at the wrist, 8 cm proximal to the abductor digiti minimi
- Proximal: 3 cm distal to the medial epicondyle of the elbow
Measured: 0 and 12 months
Nerve conduction studies: Sensory median nerve latency
Nerve conduction studies of sensory median nerve latency (milliseconds)
Median nerve measurement points:
Palmar branch, 8 cm distance, 4th digit with 14 cm distance
Measured: 0 and 12 months
Nerve conduction studies: Sensory median nerve amplitude
Nerve conduction studies of sensory median nerve amplitude (microvolts)
Median nerve measurement points:
Palmar branch, 8 cm distance, 4th digit with 14 cm distance
Measured: 0 and 12 months
Nerve conduction studies: Sensory median nerve conduction velocity
Nerve conduction studies of sensory median nerve conduction velocity (meters per second)
Median nerve measurement points:
Palmar branch, 8 cm distance, 4th digit with 14 cm distance
Measured: 0 and 12 months
Nerve conduction studies: Sensory ulnar nerve latency
Nerve conduction studies of sensory ulnar nerve latency (milliseconds)
Ulnar nerve measurement points:
Palmar branch, 8 cm distance, 4th digit with 14 cm distance
Measured: 0 and 12 months
Nerve conduction studies: Sensory ulnar nerve amplitude
Nerve conduction studies of sensory ulnar nerve amplitude (microvolts)
Ulnar nerve measurement points:
Palmar branch, 8 cm distance, 4th digit with 14 cm distance
Measured: 0 and 12 months
Nerve conduction studies: Sensory ulnar nerve conduction velocity
Nerve conduction studies of sensory ulnar nerve conduction velocity (meters per second)
Ulnar nerve measurement points:
Palmar branch, 8 cm distance, 4th digit with 14 cm distance
Measured: 0 and 12 months
Electromyography: Spontaneous activity
Electromyography recording spontaneous activity in m.abductor pollicis brevis (Yes/No)
Measured: 0 and 12 months
Electromyography: Chronic neurogenic changes
Electromyography recording chronic neurogenic changes in m.abductor pollicis brevis (Yes/No)
Measured: 0 and 12 months
Nerve conduction studies: Bland score
Scoring of motor and sensory nerve conduction studies using the Bland scoring system (Bland, et al. 2000):
- 0: normal
- 1: very mild
- 2: mild
- 3: moderate
- 4: severe
- 5: very severe
- 6: extremely severe
- 7: not gradable
Measured: 0 and 12 months
Semmes-Weinstein monofilament test
Bilateral test of sensory function in digits 1,2 and 5 using a 2.83 monofilament. Graded absent/present.
Measured: 0-24 months
Grip strength
Test of grip strength using dynamometer. Range 0-90 kg.
Measured: 0-24 months
Grip ability test (GAT)
Simplified version of the Sollerman grip function test. Measures time for subject to perform 3 tasks: Pulling a tubular bandage over the hand, putting a paper clip on an envelope, and pouring water from a jar into a cup. Range 0-60 seconds for each task. Outcome measure is calculated as: tubular bandage (seconds) x 1.8 + paper clip on an envelope (seconds) + pouring water (seconds) x 1.8
Measured: 0-24 months
Patient assessment of treatment effect on symptoms
Patient-reported assessment of treatment effect on symptoms (current state compared to before treatment), reported on a 5-level ordinal (Likert) scale from 1 (best) to 5 (worst).
Measured: 3-24 months
Patient assessment of expected treatment effect on symptoms
Patient-reported expectation (reported by the patient prior to treatment) of the treatment's effect on symptoms, reported on a 5-level ordinal (Likert) scale from 1 (best) to 5 (worst).
Measured: 0 months
Patient assessment of CTS symptoms
Patient-reported assessment of CTS-related symptoms (current state), reported on a 5-level ordinal (Likert) scale from 1 (best) to 5 (worst).
Measured: 0-24 months
Patient assessment of CTS-related functional impairment
Patient-reported assessment of current CTS-related functional impairment (current state), reported on a 5-level ordinal (Likert) scale from 1 (best) to 5 (worst).
Measured: 0-24 months
Patient assessment of acceptability of CTS-related symptoms and functional disability
Patient assessment if the current CTS-related symptoms and functional disability are acceptable (yes or no)
Measured: 0-24 months
Ultrasound measure of proximal cross-sectional area of the median nerve
Bilateral evaluation of the proximal cross-sectional area of the median nerve (square millimeters) (as specified in protocol)
Measured: 0-24 months
Ultrasound measure of distal cross-sectional area of the median nerve
Bilateral evaluation of the distal cross-sectional area of the median nerve (square millimeters) (as specified in protocol)
Measured: 0-24 months
Ultrasound measures of vascularity of the median nerve in the carpal tunnel
Bilateral evaluation of vascularity of the median nerve in the carpal tunnel. Scored 0 to 3
- 0: no PD signal
- 1: 1 singular blood vessel
- 2: 2-3 single blood vessels or 2 confluent
- 3: ≥4 single blood vessels or ≥ 3 confluent
Measured: 0-24 months
Disabilities of the Arm, Shoulder, and Hand (Quick-DASH)
11-item patient reported outcome measure for disabilities of the arm, shoulder, and hand.
(Beaton DE, et al. 2005)
Measured: 0-24 months
Patient pain assessment
Patient-reported CTS-related pain on a 0-100 mm visual analogue scale (VAS), where 0 indicates no pain and 100 indicates worst possible pain.
Measured: 0-24 months
Work Productivity and Activity Impairment Questionnaire (WPAI)
Patient-reported outcome of physical function in work and activity. (Reilly MC, et al. 1993)
Measured: 0-24 months
Days of work absence since start of intervention
Number of days of work absence due to CTS or treatment of CTS since start of intervention
Measured: 3-24 months
EuroQoL 5-dimension health-related quality of life (EQ5D-5L)
EuroQoL 5-dimension patient-reported outcome for health-related quality of life.
(Herdman M, et al. 2011)
Measured: 0-24 months
Adverse events
Number and nature of adverse events and serious adverse events
Measured: 0-24 months
Successful treatment after 1 corticosteroid injection
Only applicable in the injection treatment strategy arm. Subjects who have received 1 corticosteroid injection who have attained a successful treatment result (Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5) without surgery
Measured: 3-24 months
Successful treatment after 2 corticosteroid injections
Only applicable in the injection treatment strategy arm. Subjects who have received 2 corticosteroid injections who have attained a successful treatment result (Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5) without surgery
Measured: 3-24 months
Successful treatment after secondary surgery
Only applicable in the injection treatment strategy arm. Subjects who have received 1 or 2 corticosteroid injections and secondary surgery who have attained a successful treatment result (Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5)
Measured: 3-24 months
Undergone re-operation
Subject have received a re-operation (yes/no)
A participant who for any reason requires a re-operation, either after primary surgery (surgery arm) or after corticosteroid injection therapy and delayed surgery (injection arm). Reasons for re-operation may, for instance, be wound complications or failure of the initial procedure.
NOTE: Secondary (delayed) surgery in a participant in the injection arm in accordance with the study treatment algorithm is not considered a re-operation.
Measured: 3-24 months
Cost of treatment
Direct treatment-associated costs, including hospital visits and procedures/interventions. Based on the diagnosis-related group (DRG) pricing system and codified price-lists for medical procedures.
Measured: 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start8 Apr 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, prospective, multi-center, parallel-group, open-label assessor-blinded non-inferiority treatment strategy study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Vestre Viken Hospital Trust, South-Eastern Norway Regional Health Authority, University Hospital, Akershus
- Responsible party
- Principal investigator, Hilde Berner Hammer, Diakonhjemmet Hospital
- Investigators
- Hilde B Hammer, MD, PhD, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306548
- Sponsor's protocol ID
- DIA2021-8
- Acronym
- NOR-CACTUS
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bland JD. A neurophysiological grading scale for carpal tunnel syndrome. Muscle Nerve. 2000 Aug;23(8):1280-3. doi: 10.1002/1097-4598(200008)23:83.0.co;2-y.
PubMed 10918269Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.
PubMed 8245050Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
PubMed 15866967Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
PubMed 10146874Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NOR-CACTUS Trial - A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05306548
- Acronym / sponsor ID
- NOR-CACTUS / DIA2021-8
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Surgery, Corticosteroid injection, Ultrasound guided intervention, Nerve conduction studies, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Vestre Viken Hospital Trust, South-Eastern Norway Regional Health Authority, University Hospital, Akershus
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Carpal tunnel syndrome (CTS) causes numbness and pain in the hand and arm, and is an important cause of work absence and disability. The aim of the NOR-CACTUS Trial is to compare outcomes of a treatment strategy where the initial treatment is up to two ultrasound-guided corticosteroid injections, followed by scheduled clinical assessment of treatment effect, and subsequent surgery if needed, to a treatment strategy where surgery is the first-line treatment. Participants will be randomized to one of the treatment strategies, and followed up for two years after start of the study intervention. Outcomes will include patient-reported, clinical, functional and neurophysiological measures, and health-economic aspects. The hypothesis of the study is that there is no difference between the two treatment groups in the percentage of patients with a satisfactory symptom relief (treatment success) one year after the initial therapeutic intervention.
Detailed description
CTS is the most common non-traumatic hand disorder, prevalent in approximately 4% of the adult population. The condition may have a substantial impact on an individual's quality of life, ability to accomplish activities of daily living, and to perform occupational duties. Associated healthcare costs represent a significant socioeconomic burden.
Currently, many patients with mild and moderate CTS treated surgically without a preceding trial of less invasive non-surgical therapies. An increase in the use of non-surgical first-line therapies (e.g. corticosteroid injection into the carpal tunnel), while reserving surgery for refractory cases, aim to optimize the trade-off between treatment risk and benefit, while also ensuring appropriate use of health resources. However, there is a lack of studies directly comparing the efficacy of corticosteroid injections to surgery, and the long-term safety of corticosteroid injections has not been investigated.
It is not well-known if patients who are initially treated with corticosteroid injections will eventually need to proceed to surgery, and therefore may have to endure the symptoms for a longer period of time, with potentially worse long-term outcomes, compared to patients who has surgery as first-line treatment. On the other hand, it is not beneficial if patients are unnecessarily exposed to the risks associated with surgery, if symptoms could have been satisfactory resolved with a non-surgical method.
The current study will assess if first-line treatment with up to two ultrasound-guided corticosteroid injections is non-inferior to surgery with regards to treatment success. A less invasive treatment approach might result in important benefits to the patient, e.g. less pain, reduced risk of complications, and faster return to work and activities. This might also be of importance to family members, as many CTS patients are at an age where they have care responsibilities. Non-surgical treatments might benefit society by decreasing work absence and reducing health expenditure, and allowing better access to surgical services for other patient groups. High quality documentation is needed to provide a base for future treatment guidelines. Evidence based clinical guidelines provide treatment decision support and help reduce national and regional differences in treatment practices, and ensure that all patients have equal access to evidence-based treatment.
In the NOR-CACTUS trial, adult individuals with idiopathic CTS of a mild-to-moderate degree will be randomized to receive either A) Primary open surgical carpal tunnel release, or B) Up to two ultrasound-guided corticosteroid (triamcinolone hexacetonide) injections in the carpal tunnel, and subsequent open surgical carpal tunnel release in case of unsatisfactory treatment result. Participants will be randomized to receive one of the treatment strategies, and followed for two years, with the primary endpoint being successful treatment result one year after start of the intervention.
The hypothesis of the study is that the percentage of patients with a satisfactory symptom relief (treatment success) one year after the initial therapeutic intervention in the injection treatment strategy arm is non-inferior to that of the surgery treatment arm. The primary outcome is based on the disease-specific patient-reported outcome Boston Carpal Tunnel Questionnaire (BCTQ) symptom severity scale (SSS). Further outcomes will include other patient-reported, clinical, functional and neurophysiological measures, and health-economic aspects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, prospective, multi-center, parallel-group, open-label assessor-blinded non-inferiority treatment strategy study
| Arm | Type | Receives |
|---|---|---|
| Surgery treatment strategy | Active comparator | Procedure: Surgical carpal tunnel releasePrimary open surgical carpal tunnel release. Treatment effect is monitored on scheduled follow-up visits. Re-operation may be performed if medically indicated (e.g. postoperative complication, or failure of the primary procedure) |
| Injection treatment strategy | Experimental | Procedure: Surgical carpal tunnel release, Drug: Injection, Triamcinolone Hexacetonide, Per 5 MgPrimary treatment with ultrasound-guided corticosteroid injection. Treatment effect is monitored on scheduled follow-up visits. One additional injection may be administered, and subsequently surgical carpal tunnel release is performed in case of unsatisfactory treatment effect of the injection therapy. Treatment effect is graded on a 5-leve scale by subject from 1 (complete improvement) to 5 (severe worsening) of symptoms. Incomplete improvement (score 2 or higher) results in a second injection or secondary surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult (≥18 years of age)
- Patient history indicating CTS
- Neurophysiological examination performed within 6 months
- Diagnosis of CTS based on:
- Mild to moderate symptoms (intermittent, interfering with everyday life, and/or disturb sleep)
Key exclusion criteria (16 listed)
- Previous CTS surgery or corticosteroid injection in the carpal tunnel in the relevant hand
- Diagnosis of severe CTS, based on history and examination indicating severe CTS with constant symptoms including pain, loss of sensibility, dexterity or reduced temperature sensation, weakness of thumb abduction and opposition, or atrophy of thenar musculature. Disappearance of pain may indicate permanent sensory loss.
- History suggesting underlying causes of CTS e.g. inflammatory wrist arthritis and/or flexor tenosynovitis
- Previous significant trauma or fracture, deformity or tumor in the wrist or hand in the relevant hand
- Presence of conditions affecting a normal nerve function e.g. cervical disc herniation, polyneuropathy or previous nerve injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical carpal tunnel releaseAlso: Open surgical carpal tunnel releaseOpen surgical division of the flexor retinaculum of the palm/wrist to release pressure on the median nerve | Procedure or surgery | Injection treatment strategy, Surgery treatment strategy |
| Injection, Triamcinolone Hexacetonide, Per 5 MgAlso: Ultrasound-guided corticosteroid injectionUltrasound-guided injection of 20 mg of triamcinolone hexacetonide (or -acetonide) into the carpal tunnel space close to the median nerve | Drug | Injection treatment strategy |
Primary outcome
Successful treatment result after 12 months
Time frame: 12 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5 after 12 months Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5. The primary outcome measure is achievement of BCTQ SSS ≤ 1.5, interpreted as a successful treatment result, 12 months after start of the study intervention.
44 secondary outcomes
Successful treatment result after 3 months
Time frame: 3 months
Successful treatment result after 6 months
Time frame: 6 months
Successful treatment result after 24 months
Time frame: 24 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale
Time frame: 0-24 months
Boston Carpal Tunnel Questionnaire Functional Status Scale
Time frame: 0-24 months
Nerve conduction studies: Motor median nerve distal latency
Time frame: 0 and 12 months
Nerve conduction studies: Motor median nerve proximal latency
Time frame: 0 and 12 months
Nerve conduction studies: Motor median nerve amplitude
Time frame: 0 and 12 months
Nerve conduction studies: Motor median nerve conduction velocity
Time frame: 0 and 12 months
Nerve conduction studies: Motor ulnar nerve distal latency
Time frame: 0 and 12 months
Nerve conduction studies: Motor ulnar nerve proximal latency
Time frame: 0 and 12 months
Nerve conduction studies: Motor ulnar nerve amplitude
Time frame: 0 and 12 months
Nerve conduction studies: Motor ulnar nerve conduction velocity
Time frame: 0 and 12 months
Nerve conduction studies: Sensory median nerve latency
Time frame: 0 and 12 months
Nerve conduction studies: Sensory median nerve amplitude
Time frame: 0 and 12 months
Nerve conduction studies: Sensory median nerve conduction velocity
Time frame: 0 and 12 months
Nerve conduction studies: Sensory ulnar nerve latency
Time frame: 0 and 12 months
Nerve conduction studies: Sensory ulnar nerve amplitude
Time frame: 0 and 12 months
Nerve conduction studies: Sensory ulnar nerve conduction velocity
Time frame: 0 and 12 months
Electromyography: Spontaneous activity
Time frame: 0 and 12 months
Electromyography: Chronic neurogenic changes
Time frame: 0 and 12 months
Nerve conduction studies: Bland score
Time frame: 0 and 12 months
Semmes-Weinstein monofilament test
Time frame: 0-24 months
Grip strength
Time frame: 0-24 months
Grip ability test (GAT)
Time frame: 0-24 months
Patient assessment of treatment effect on symptoms
Time frame: 3-24 months
Patient assessment of expected treatment effect on symptoms
Time frame: 0 months
Patient assessment of CTS symptoms
Time frame: 0-24 months
Patient assessment of CTS-related functional impairment
Time frame: 0-24 months
Patient assessment of acceptability of CTS-related symptoms and functional disability
Time frame: 0-24 months
Ultrasound measure of proximal cross-sectional area of the median nerve
Time frame: 0-24 months
Ultrasound measure of distal cross-sectional area of the median nerve
Time frame: 0-24 months
Ultrasound measures of vascularity of the median nerve in the carpal tunnel
Time frame: 0-24 months
Disabilities of the Arm, Shoulder, and Hand (Quick-DASH)
Time frame: 0-24 months
Patient pain assessment
Time frame: 0-24 months
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: 0-24 months
Days of work absence since start of intervention
Time frame: 3-24 months
EuroQoL 5-dimension health-related quality of life (EQ5D-5L)
Time frame: 0-24 months
Adverse events
Time frame: 0-24 months
Successful treatment after 1 corticosteroid injection
Time frame: 3-24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 10918269Bland JD. A neurophysiological grading scale for carpal tunnel syndrome. Muscle Nerve. 2000 Aug;23(8):1280-3. doi: 10.1002/1097-4598(200008)23:83.0.co;2-y.
- Background: PubMed 8245050Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.
- Background: PubMed 15866967Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
- Background: PubMed 10146874Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
- Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilde B Hammer, MD, PhD principal investigator
Diakonhjemmet Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical carpal tunnel release and Injection, Triamcinolone Hexacetonide, Per 5 Mg in people with Carpal Tunnel Syndrome, run by Diakonhjemmet Hospital at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful treatment result after 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306548, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.