- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509633
Effects of Pain Neuroscience Education and Standard Rehabilitation Regime in Patients of Carpal Tunnel Syndrome
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: imran amjad
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
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Punjab
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Lahore, Punjab, Pakistan, 56300
- Recruiting
- Absaar medical center
-
Contact:
- Iqra khan
- Phone Number: 03354671744
- Email: Iqrakhan485@gmail.com
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Principal Investigator:
- Sara Abdulhaq
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pain Neuroscience education and Standard Rehabilitation regime
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.
|
Median nerve gliding exercises, wrist and forearm muscle stretches, wrist mobilizations and finger joint mobilizations
Other Names:
|
|
Active Comparator: standard Rehabilitation regime
Patient will get only nerve gliding and wrist forearm muscle stretching exercises.
|
standard Rehabilitation regime
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
Time Frame: 4th week
|
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".
|
4th week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Boston Carpal Tunnel Questionnaire (BCTQ)
Time Frame: 4th week
|
BCTQmeasures self reported functional status and severity of symptom.
The BCTQ-SSS consists of 11 questions, each question provides 5 response choices, from 1 (no symptoms) to 5 (most severe/often).
|
4th week
|
|
Goniometer
Time Frame: 4th week
|
The range of motions like flexion extension radial deviation and ulnar deviation of wrist will be measured by Goniometer.
|
4th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saba khan, Riphah International University
Publications and helpful links
General Publications
- 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.
- Ballestero-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.
- Genova 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.
- Louw 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.
- Werner RA, Andary M. Electrodiagnostic evaluation of carpal tunnel syndrome. Muscle Nerve. 2011 Oct;44(4):597-607. doi: 10.1002/mus.22208.
- Nunez-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.
- Nunez-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.
- Bulow 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.
- Ziegler 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.
- Lopez-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.
- Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychological assessment. 1995;7(4):524.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Wounds and Injuries
- Disease
- Neuromuscular Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Median Neuropathy
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Arm Injuries
- Syndrome
- Carpal Tunnel Syndrome
- Wrist Injuries
Other Study ID Numbers
- REC/RCR&AHS/23/01113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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