Wrist InjuriesNCT06509633
Effects of Pain Neuroscience Education and Standard Rehabilitation Regime in Patients of Carpal Tunnel Syndrome
A study testing Pain Neuroscience education and standard rehabilitation regime and standard Rehabilitation regime in people with Wrist Injuries and Carpal Tunnel Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to check the effects of Pain Neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Wrist Injuries, Carpal Tunnel Syndrome
- What is being tested?
- Pain Neuroscience education and standard rehabilitation regime and standard Rehabilitation regime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 10 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age between 20_40 years old.
- Medical diagnosis of moderate to severe CTS.
- Symptoms of CTS since 1month
- Unilateral or bilateral symptoms
- Availability and access to the hospital.
Who cannot join
- Inability to understand instructions, neurological conditions of the central nervous system (e.g. stroke, spinal cord injury)
- Patients on treatment with alternative therapies
- Previous participation in a research program
- Previous surgery on the affected upper limb
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Absaar medical center
Lahore, Punjab Province, 56300
Iqra khan, 03354671744, Iqrakhan485@gmail.com
Sara Abdulhaq
About this study
The aim of this study is to check the effects of Pain Neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome.
Read the detailed description
In 2017 a stud assessed effectiveness of standard conservative protocol of CTS and nerve mobilization along with and without PNE and documented that standard conservative care seems to be the most appropriate option for pain relief, although neuroscience education might be a complementary option to accelerate recovery of function. More high-quality research is still necessary to determine its effectiveness and the subgroups of patients who may respond better to this treatment.
In 2019 a study was done to assess the effect of PNE and standard rehabilitation exercises on the 41 patients of CTS. The experimenting group was given one session of PNE plus exercises and the control group was given exercise therapy only. Patients were randomly allocated and double blinded. The analysis of study showed better results with experimental group rather than control group.
Many studies have found the effects of standard rehabilitation of Carpal Tunnel syndrome and their results in controlling pain and dysfunction. However as per researchers' knowledge little literature is available on effects of pain neuroscience education and standard rehabilitation regime in carpal tunnel syndrome. Therefore, this study6 is going to determine the effects of effectiveness of Pain Neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome.
- Conditions
- Wrist Injuries, Carpal Tunnel Syndrome
- Being tested
- Pain Neuroscience education and standard rehabilitation regime, standard Rehabilitation regime
- Keywords
- Carpal tunnel syndrome, Compression, Pain neuroscience education, Median nerve
- Medical subject headings
- Wrist Injuries, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience education and standard rehabilitation regimeOther
Also called Standard Rehabilitation regime
Median nerve gliding exercises, wrist and forearm muscle stretches, wrist mobilizations and finger joint mobilizations
standard Rehabilitation regimeOther
standard Rehabilitation regime
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience education and Standard Rehabilitation regime | Experimental | Patients will get standard treatment of CTS, which is nerve gliding, stretchings of forearm and wrist muscles and wrist mobilization along with pain neuroscience education. Receives: Other: Pain Neuroscience education and standard rehabilitation regime |
| standard Rehabilitation regime | Active comparator | Patient will get only nerve gliding and wrist forearm muscle stretching exercises. Receives: Other: standard Rehabilitation regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rate scale (NPRS)
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain.
Measured: 4th week
Secondary outcomes (1)
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) was used to measure catastrophic thinking in response to pain through 13 statements with four possible options, from 1 "not at all" to 4 "all the time".
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Feb 2024
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Wrist InjuriesStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba khan, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509633
- Sponsor's protocol ID
- REC/RCR&AHS/23/01113
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Werner RA, Andary M. Electrodiagnostic evaluation of carpal tunnel syndrome. Muscle Nerve. 2011 Oct;44(4):597-607. doi: 10.1002/mus.22208.
PubMed 21922474Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.
PubMed 32313774Nunez-Cortes R, Espinoza-Ordonez C, Pommer PP, Horment-Lara G, Perez-Alenda S, Cruz-Montecinos C. A single preoperative pain neuroscience education: Is it an effective strategy for patients with carpal tunnel syndrome? Med Hypotheses. 2019 May;126:46-50. doi: 10.1016/j.mehy.2019.03.013. Epub 2019 Mar 22.
PubMed 31010499Nunez-Cortes R, Cruz-Montecinos C, Torreblanca-Vargas S, Tapia C, Gutierrez-Jimenez M, Torres-Gangas P, Calatayud J, Perez-Alenda S. Effectiveness of adding pain neuroscience education to telerehabilitation in patients with carpal tunnel syndrome: A randomized controlled trial. Musculoskelet Sci Pract. 2023 Oct;67:102835. doi: 10.1016/j.msksp.2023.102835. Epub 2023 Jul 28.
PubMed 37572618Ballestero-Perez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atin-Arratibel MLA, Pecos-Martin D, Gallego-Izquierdo T, Romero-Franco N. Effectiveness of Nerve Gliding Exercises on Carpal Tunnel Syndrome: A Systematic Review. J Manipulative Physiol Ther. 2017 Jan;40(1):50-59. doi: 10.1016/j.jmpt.2016.10.004. Epub 2016 Nov 11.
PubMed 27842937Bulow K, Lindberg K, Vaegter HB, Juhl CB. Effectiveness of Pain Neurophysiology Education on Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Pain Med. 2021 Apr 20;22(4):891-904. doi: 10.1093/pm/pnaa484.
PubMed 33764394Louw A, Puentedura EJ, Zimney K, Schmidt S. Know Pain, Know Gain? A Perspective on Pain Neuroscience Education in Physical Therapy. J Orthop Sports Phys Ther. 2016 Mar;46(3):131-4. doi: 10.2519/jospt.2016.0602.
PubMed 26928735Ziegler AM, Minkalis AL, Langdon ER, Vining R. Learning the neurobiology of pain: A scoping review of pain education from an instructional design perspective. Patient Educ Couns. 2022 Jun;105(6):1379-1401. doi: 10.1016/j.pec.2021.09.021. Epub 2021 Sep 14.
PubMed 34579995Lopez-de-Uralde-Villanueva I, Fernandez-de-Las-Penas C, Cleland JA, Cook C, de-la-Llave-Rincon AI, Valera-Calero JA, Plaza-Manzano G. Minimal Clinically Important Differences in Hand Pain Intensity (Numerical Pain Rate Scale) and Related-Function (Boston Carpal Tunnel Questionnaire) in Women With Carpal Tunnel Syndrome. Arch Phys Med Rehabil. 2024 Jan;105(1):67-74. doi: 10.1016/j.apmr.2023.07.018. Epub 2023 Aug 13.
PubMed 37582474Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychological assessment. 1995;7(4):524.
Levine 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 8245050
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pain Neuroscience Education and Standard Rehabilitation Regime in Patients of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06509633
- Acronym / sponsor ID
- REC/RCR&AHS/23/01113
- Conditions
- Wrist Injuries, Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, Compression, Pain neuroscience education, Median nerve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Nov 2024 (estimated)
- First posted
- 19 Jul 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.
The aim of this study is to check the effects of Pain Neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome.
Detailed description
In 2017 a stud assessed effectiveness of standard conservative protocol of CTS and nerve mobilization along with and without PNE and documented that standard conservative care seems to be the most appropriate option for pain relief, although neuroscience education might be a complementary option to accelerate recovery of function. More high-quality research is still necessary to determine its effectiveness and the subgroups of patients who may respond better to this treatment.
In 2019 a study was done to assess the effect of PNE and standard rehabilitation exercises on the 41 patients of CTS. The experimenting group was given one session of PNE plus exercises and the control group was given exercise therapy only. Patients were randomly allocated and double blinded. The analysis of study showed better results with experimental group rather than control group.
Many studies have found the effects of standard rehabilitation of Carpal Tunnel syndrome and their results in controlling pain and dysfunction. However as per researchers' knowledge little literature is available on effects of pain neuroscience education and standard rehabilitation regime in carpal tunnel syndrome. Therefore, this study6 is going to determine the effects of effectiveness of Pain Neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience education and Standard Rehabilitation regime | Experimental | Other: Pain Neuroscience education and standard rehabilitation regimePatients will get standard treatment of CTS, which is nerve gliding, stretchings of forearm and wrist muscles and wrist mobilization along with pain neuroscience education. |
| standard Rehabilitation regime | Active comparator | Other: standard Rehabilitation regimePatient will get only nerve gliding and wrist forearm muscle stretching exercises. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age between 20_40 years old.
- Medical diagnosis of moderate to severe CTS.
- Symptoms of CTS since 1month
- Unilateral or bilateral symptoms
- Availability and access to the hospital.
Key exclusion criteria (4 listed)
- Inability to understand instructions, neurological conditions of the central nervous system (e.g. stroke, spinal cord injury)
- Patients on treatment with alternative therapies
- Previous participation in a research program
- Previous surgery on the affected upper limb
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 |
|---|---|---|
| Pain Neuroscience education and standard rehabilitation regimeAlso: Standard Rehabilitation regimeMedian nerve gliding exercises, wrist and forearm muscle stretches, wrist mobilizations and finger joint mobilizations | Other | Pain Neuroscience education and Standard Rehabilitation regime |
| standard Rehabilitation regimestandard Rehabilitation regime | Other | standard Rehabilitation regime |
Primary outcome
Numeric pain rate scale (NPRS)
Time frame: 4th week
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain.
1 secondary outcome
Pain Catastrophizing Scale (PCS)
Time frame: 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 21922474Werner RA, Andary M. Electrodiagnostic evaluation of carpal tunnel syndrome. Muscle Nerve. 2011 Oct;44(4):597-607. doi: 10.1002/mus.22208.
- Background: PubMed 32313774Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.
- Background: PubMed 31010499Nunez-Cortes R, Espinoza-Ordonez C, Pommer PP, Horment-Lara G, Perez-Alenda S, Cruz-Montecinos C. A single preoperative pain neuroscience education: Is it an effective strategy for patients with carpal tunnel syndrome? Med Hypotheses. 2019 May;126:46-50. doi: 10.1016/j.mehy.2019.03.013. Epub 2019 Mar 22.
- Background: PubMed 37572618Nunez-Cortes R, Cruz-Montecinos C, Torreblanca-Vargas S, Tapia C, Gutierrez-Jimenez M, Torres-Gangas P, Calatayud J, Perez-Alenda S. Effectiveness of adding pain neuroscience education to telerehabilitation in patients with carpal tunnel syndrome: A randomized controlled trial. Musculoskelet Sci Pract. 2023 Oct;67:102835. doi: 10.1016/j.msksp.2023.102835. Epub 2023 Jul 28.
- Background: PubMed 27842937Ballestero-Perez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atin-Arratibel MLA, Pecos-Martin D, Gallego-Izquierdo T, Romero-Franco N. Effectiveness of Nerve Gliding Exercises on Carpal Tunnel Syndrome: A Systematic Review. J Manipulative Physiol Ther. 2017 Jan;40(1):50-59. doi: 10.1016/j.jmpt.2016.10.004. Epub 2016 Nov 11.
- Background: PubMed 33764394Bulow K, Lindberg K, Vaegter HB, Juhl CB. Effectiveness of Pain Neurophysiology Education on Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Pain Med. 2021 Apr 20;22(4):891-904. doi: 10.1093/pm/pnaa484.
- Background: PubMed 26928735Louw A, Puentedura EJ, Zimney K, Schmidt S. Know Pain, Know Gain? A Perspective on Pain Neuroscience Education in Physical Therapy. J Orthop Sports Phys Ther. 2016 Mar;46(3):131-4. doi: 10.2519/jospt.2016.0602.
- Background: PubMed 34579995Ziegler AM, Minkalis AL, Langdon ER, Vining R. Learning the neurobiology of pain: A scoping review of pain education from an instructional design perspective. Patient Educ Couns. 2022 Jun;105(6):1379-1401. doi: 10.1016/j.pec.2021.09.021. Epub 2021 Sep 14.
- Background: PubMed 37582474Lopez-de-Uralde-Villanueva I, Fernandez-de-Las-Penas C, Cleland JA, Cook C, de-la-Llave-Rincon AI, Valera-Calero JA, Plaza-Manzano G. Minimal Clinically Important Differences in Hand Pain Intensity (Numerical Pain Rate Scale) and Related-Function (Boston Carpal Tunnel Questionnaire) in Women With Carpal Tunnel Syndrome. Arch Phys Med Rehabil. 2024 Jan;105(1):67-74. doi: 10.1016/j.apmr.2023.07.018. Epub 2023 Aug 13.
- BackgroundSullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychological assessment. 1995;7(4):524.
- 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.
- 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. This study is not recruiting at the moment.
Saba khan 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 Pain Neuroscience education and standard rehabilitation regime and standard Rehabilitation regime in people with Wrist Injuries and Carpal Tunnel Syndrome, 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad (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 rate scale (NPRS) (time frame: 4th week). 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 NCT06509633, which also lists 11 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 19 Jul 2024.