Carpal Tunnel Syndrome (CTS)NCT06687018
Effects of Kaltenborn and Mulligan Mobilisation in Patients With Carpal Tunnel Syndrome.
A study testing Kaltenborn mobilisation and Mulligan mobilisation in people with Carpal Tunnel Syndrome (CTS), run by Riphah International University at 1 site in Pakistan.
Trial summary
Carpal Tunnel Syndrome is the most common mononeuropathy that results from the compression of median nerve in carpal tunnel, leading to entrapment neuropathy. The symptoms become aggravated during drawing, typing or playing video games. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Kaltenborn mobilisation and Mulligan mobilisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Jan 2024to 7 Jan 2025
- Phase
- Interventional
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders between 20 and 45 years of age
- Individuals having localized pain, tingling and numbness in the median nerve distribution
- Positive Tinel sign and positive Phalen's test
Who cannot join
- Any sensory and/or motor deficit in either the ulnar or radial nerve traumatic neck injury
- Previous hand surgery or trauma or cervical radiculopathy
- Systemic disease e.g. diabetes mellitus or thyroid disease or rheumatoid arthritis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Ejaz Hospital
Lahore, Punjab Province
Aqeel Ilyas, MS-NMPT, +923037862835, ilyassaqeel@gmail.com
Muhammad Nauman, MS-OMPT
About this study
Official title: Comparative Effects of Kaltenborn Versus Mulligan Mobilisation on Pain, Disability and Hand Function in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome is the most common mononeuropathy that results from the compression of median nerve in carpal tunnel, leading to entrapment neuropathy. The symptoms become aggravated during drawing, typing or playing video games. The aim of study will be to compare the effects of Kaltenborn and Mulligan mobilisation on pain, disability and hand function in patients with carpal tunnel syndrome.
Read the detailed description
This research will adopt a Randomized Clinical Trial design. Upon approval of the synopsis, ethical clearance would be taken and necessary permissions from Ejaz Hospital Lahore. Through convenience sampling technique, 48 patients will be included which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Mobilisation technique includes moving the proximal row of carpal bones either dorsally to promote wrist extension or to the palmar side to promote wrist flexion. Group A will be treated with Grade 3 Kaltenborn mobilisation. Grade 3 distraction was chosen to avoid contact between the articular surfaces and to stimulate hypoalgesic factors and Group B will be treated with Mulligan mobilisation. Outcome measures will be conducted through pain, disability and hand function questionnaire after 6 weeks. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Kaltenborn mobilisation, Mulligan mobilisation
- Keywords
- Kaltenborn, Mulligan, Pain, Disability, Hand Function, CTS
- Medical subject headings
- Carpal Tunnel Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaltenborn mobilisationOther
Kaltenborn mobilisation Grade 3 along with common treatment for 3 minutes, repeated 3 sets with rest of 1 minutes, three sessions per week for four weeks. Conventional treatment comprises a hot pack for 10 minutes, SWD for 5 minutes, and nerve and tendon gliding exercises.
Mulligan mobilisationOther
Mulligan mobilisation with 10 repetitions with 3 sets and three sessions per week for four weeks. Conventional treatment comprises a hot pack for 10 minutes, SWD for 5 minutes, and nerve and tendon gliding exercises
| Study group | Role | What they receive |
|---|---|---|
| Kaltenborn mobilisation | Experimental | Kaltenborn mobilisation along with conventional treatment. Receives: Other: Kaltenborn mobilisation |
| Mulligan mobilisation | Active comparator | Mulligan mobilisation along with conventional treatment. Receives: Other: Mulligan mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Changes from baseline, Numeric Rating Scale (NRS) is the most commonly used scale in which the pain rate ranges from 0 (no pain) to 10 (worst pain). The NPRS has validity of 0.86 to 0.95 and reliability of 0.96.
Measured: 4 weeks
Boston Carpal Tunnel Questionnaire
Questionnaire used to assess functional status and symptom severity. There are two subscales in BCTQ. The Functional Status Scale evaluates hand function, whereas the Symptom Severity Scale (SSS) provides PRO data on the degree of symptoms. Eleven items make up the Symptom Severity scale, which rates symptoms related to pain, paresthesia, numbness, weakness, and grasping trouble. Eight items make up the Functional Status Scale (FSS), which evaluates functional deficiencies. Form 1 (no symptoms/difficulties) to 5 (worst symptoms/cannot do the task at all) each item is graded.(20). In BCQT, SSS has reliability 0.89 and FSS has 0.93.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start4 Jan 2024
- Primary completion7 Jan 2025 (estimated)
- Study completion7 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Raza, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687018
- Sponsor's protocol ID
- REC/RCR & AHS/24/0129
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bougea A, Zambelis T, Voskou P, Katsika PZ, Tzavara C, Kokotis P, Karandreas N. Reliability and Validation of the Greek Version of the Boston Carpal Tunnel Questionnaire. Hand (N Y). 2018 Sep;13(5):593-599. doi: 10.1177/1558944717725379. Epub 2017 Aug 20.
PubMed 28825339Abdolrazaghi HA, Khansari M, Mirshahi M, Ahmadi Pishkuhi M. Effectiveness of Tendon and Nerve Gliding Exercises in the Treatment of Patients With Mild Idiopathic Carpal Tunnel Syndrome: A Randomized Controlled Trial. Hand (N Y). 2023 Mar;18(2):222-229. doi: 10.1177/15589447211006857. Epub 2021 Apr 15.
PubMed 33855879Exelby L. Peripheral mobilisations with movement. Man Ther. 1996 Jun;1(3):118-126. doi: 10.1054/math.1996.0259.
PubMed 11440498Spagnoli AM, Fino P, Fioramonti P, Sanese G, Scuderi N. Bifid median nerve and carpal tunnel syndrome: an uncommon anatomical variation. Ann Ital Chir. 2017;88:95-96.
PubMed 28447963Li ZM, Jordan DB. Carpal tunnel mechanics and its relevance to carpal tunnel syndrome. Hum Mov Sci. 2023 Feb;87:103044. doi: 10.1016/j.humov.2022.103044. Epub 2022 Nov 25.
PubMed 36442295Talebi GA, Saadat P, Javadian Y, Taghipour M. Comparison of two manual therapy techniques in patients with carpal tunnel syndrome: A randomized clinical trial. Caspian J Intern Med. 2020;11(2):163-170. doi: 10.22088/cjim.11.2.163.
PubMed 32509244
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Kaltenborn Versus Mulligan Mobilisation on Pain, Disability and Hand Function in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06687018
- Acronym / sponsor ID
- REC/RCR & AHS/24/0129
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Kaltenborn, Mulligan, Pain, Disability, Hand Function, CTS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 7 Jan 2025 (estimated)
- Study completion
- 7 Jan 2025 (estimated)
- First posted
- 13 Nov 2024 (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 is the most common mononeuropathy that results from the compression of median nerve in carpal tunnel, leading to entrapment neuropathy. The symptoms become aggravated during drawing, typing or playing video games. The aim of study will be to compare the effects of Kaltenborn and Mulligan mobilisation on pain, disability and hand function in patients with carpal tunnel syndrome.
Detailed description
This research will adopt a Randomized Clinical Trial design. Upon approval of the synopsis, ethical clearance would be taken and necessary permissions from Ejaz Hospital Lahore. Through convenience sampling technique, 48 patients will be included which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Mobilisation technique includes moving the proximal row of carpal bones either dorsally to promote wrist extension or to the palmar side to promote wrist flexion. Group A will be treated with Grade 3 Kaltenborn mobilisation. Grade 3 distraction was chosen to avoid contact between the articular surfaces and to stimulate hypoalgesic factors and Group B will be treated with Mulligan mobilisation. Outcome measures will be conducted through pain, disability and hand function questionnaire after 6 weeks. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kaltenborn mobilisation | Experimental | Other: Kaltenborn mobilisationKaltenborn mobilisation along with conventional treatment. |
| Mulligan mobilisation | Active comparator | Other: Mulligan mobilisationMulligan mobilisation along with conventional treatment. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both genders between 20 and 45 years of age
- Individuals having localized pain, tingling and numbness in the median nerve distribution
- Positive Tinel sign and positive Phalen's test
Key exclusion criteria (3 listed)
- Any sensory and/or motor deficit in either the ulnar or radial nerve traumatic neck injury
- Previous hand surgery or trauma or cervical radiculopathy
- Systemic disease e.g. diabetes mellitus or thyroid disease or rheumatoid arthritis
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 |
|---|---|---|
| Kaltenborn mobilisationKaltenborn mobilisation Grade 3 along with common treatment for 3 minutes, repeated 3 sets with rest of 1 minutes, three sessions per week for four weeks. Conventional treatment comprises a hot pack for 10 minutes, SWD for 5 minutes, and nerve and tendon gliding exercises. | Other | Kaltenborn mobilisation |
| Mulligan mobilisationMulligan mobilisation with 10 repetitions with 3 sets and three sessions per week for four weeks. Conventional treatment comprises a hot pack for 10 minutes, SWD for 5 minutes, and nerve and tendon gliding exercises | Other | Mulligan mobilisation |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4 weeks
Changes from baseline, Numeric Rating Scale (NRS) is the most commonly used scale in which the pain rate ranges from 0 (no pain) to 10 (worst pain). The NPRS has validity of 0.86 to 0.95 and reliability of 0.96.
Boston Carpal Tunnel Questionnaire
Time frame: 4 weeks
Questionnaire used to assess functional status and symptom severity. There are two subscales in BCTQ. The Functional Status Scale evaluates hand function, whereas the Symptom Severity Scale (SSS) provides PRO data on the degree of symptoms. Eleven items make up the Symptom Severity scale, which rates symptoms related to pain, paresthesia, numbness, weakness, and grasping trouble. Eight items make up the Functional Status Scale (FSS), which evaluates functional deficiencies. Form 1 (no symptoms/difficulties) to 5 (worst symptoms/cannot do the task at all) each item is graded.(20). In BCQT, SSS has reliability 0.89 and FSS has 0.93.
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 13 Nov 2024.
- Background: PubMed 28825339Bougea A, Zambelis T, Voskou P, Katsika PZ, Tzavara C, Kokotis P, Karandreas N. Reliability and Validation of the Greek Version of the Boston Carpal Tunnel Questionnaire. Hand (N Y). 2018 Sep;13(5):593-599. doi: 10.1177/1558944717725379. Epub 2017 Aug 20.
- Background: PubMed 33855879Abdolrazaghi HA, Khansari M, Mirshahi M, Ahmadi Pishkuhi M. Effectiveness of Tendon and Nerve Gliding Exercises in the Treatment of Patients With Mild Idiopathic Carpal Tunnel Syndrome: A Randomized Controlled Trial. Hand (N Y). 2023 Mar;18(2):222-229. doi: 10.1177/15589447211006857. Epub 2021 Apr 15.
- Background: PubMed 11440498Exelby L. Peripheral mobilisations with movement. Man Ther. 1996 Jun;1(3):118-126. doi: 10.1054/math.1996.0259.
- Background: PubMed 28447963Spagnoli AM, Fino P, Fioramonti P, Sanese G, Scuderi N. Bifid median nerve and carpal tunnel syndrome: an uncommon anatomical variation. Ann Ital Chir. 2017;88:95-96.
- Background: PubMed 36442295Li ZM, Jordan DB. Carpal tunnel mechanics and its relevance to carpal tunnel syndrome. Hum Mov Sci. 2023 Feb;87:103044. doi: 10.1016/j.humov.2022.103044. Epub 2022 Nov 25.
- Background: PubMed 32509244Talebi GA, Saadat P, Javadian Y, Taghipour M. Comparison of two manual therapy techniques in patients with carpal tunnel syndrome: A randomized clinical trial. Caspian J Intern Med. 2020;11(2):163-170. doi: 10.22088/cjim.11.2.163.
- Individual participant dataSharing planned: No
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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.
Ali Raza, MS-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaltenborn mobilisation and Mulligan mobilisation in people with Carpal Tunnel Syndrome (CTS), run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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.
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?
Contact Imran Amjad, Phd (03324390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT06687018, which also lists 6 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 13 Nov 2024.