- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04733209
Mobilization With Movement in Carpal Tunnel Syndrome.
Investigation of the Effectiveness of Movement With Mobilization Technique for Carpal Tunnel Syndrome.
Peripheral nerve impingement neuropathies are the most common mononeuropathies encountered in clinical practice. Carpal Tunnel Syndrome (CTS) occurs as a result of compression of the median nerve as it passes through the carpal tunnel, a narrow osteofibrous canal. CTS is the most common entrapment neuropathy of the upper extremity, affecting approximately 3% of the general population.
Massage and mobilization techniques are used in the treatment of CTS due to their analgesic effects. The painless mobilization with movement technique (MWM, developed by Brian Mulligan) is a manual therapy method applies to correct the limitation of movement in the joint and to relieve pain and functional disorders. Many studies have shown that MWM technique provides faster and momentary painless joint movement compared to other physical therapy modalities.
The patient group with CTS has a large place in the general population and long treatment processes cause both labour loss and economic loss. In the literature review, there is no study examining the effects of MWM in patients with CTS. Therefore, this study aimed to examine the effectiveness of MWM technique in cases with CTS.
Study Overview
Detailed Description
In this study, 45 CTS patients with age range 18-65 who applied to Kırşehir Ahi Evran University Training and Research Hospital were examined. The individuals included in the study were divided into two groups according to the paired randomization method. These groups were control and intervention groups. Traditional physiotherapy methods were applied to the control group, traditional physiotherapy and MWM techniques were applied to the intervention group. Traditional physiotherapy methods were included; Transcutaneous Electrical Nerve Stimulation (TENS), Ultrasound (US), tendon-nerve gliding exercises, night splint, stretching and strengthening exercises.
For the evaluation of patients; Visual Analogue Scale (VAS), wrist goniometric measurements, grip strength measurement, pinch strength measurement, edema measurement, Electromyography (EMG), Nelson Hand Reaction Test, Upper Limb Disorders Arm Shoulder and Hand Problems Questionnaire (DASH), Boston Carpal The Tunnel Injury Questionnaire and Michigan Hand Result Questionnaire (MHRQ) was used.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
İç Anadolu
-
Kırşehir, İç Anadolu, Turkey, 40500
- Kırşehir Ahi Evran Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Lasting longer than six weeks in the area associated with the n. medianus; Paresthesia, pain, and vasomotor symptoms.
A positive Phalen, Tinel or carpal compression test on wrist examination. In neurophysiological evaluation mild to moderate severity of the n. medianus lesion
Exclusion Criteria:
• Radial or ulnar nerve sensory-motor findings accompanying the current condition. Under the age of 18 and over the age of 65.
- Having undergone upper extremity surgery or steroid injection for any reason. Having a history of another disease or trauma in the upper extremity.
- Having a history of systemic disease such as diabetes or thyroid disease, which may lead to CTS.
Pregnancy.
- Any contraindications for the patient to exercise,
- The patient has any mental problems.
- In neurophysiological evaluation severe n. medianus lesion severity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobilization with movement
Mobilization with movement technique and traditional physiotherapy were applied to the intervention group. For mobilization with movement technique, the patient was asked to actively flex and extend the wrist with the forearm in neutral in a sitting position on a treatment table, and the pain was asked. The painful side was determined according to the patient's statement. In a patient whose painful side was flexion, the wrist joint was shifted manually (with the help of the web space of both hands of the therapist) to the lateral and medial at the same time while the patient actively flexed the wrist. The treatment was done 3 times a week for 4 weeks. |
Physiotherapy
|
Active Comparator: Conventional
Traditional physiotherapy techniques were applied to the intervention group.
Conventional TENS type was used.
Current transition time was set as 50-100 µs.
TENS application is performed at a frequency of 100 Hertz for 20 minutes in amplitude that does not cause muscle contraction in the patient and creates a feeling of numbness and tingling.
Continuous ultrasound type was applied with full contact technique.
Ultrasound treatment was applied over the transverse carpal ligament in the wrist with circular movements towards the proximal and distal at a speed of 1-2.5 cm per second, at a dose of 1 W / cm2, for 6 minutes, with a frequency of 3 MHz.
And; tendon-nerve gliding exercises, night splint, stretching and strengthening exercises applied.
The treatment was done 3 times a week for 4 weeks.
|
Physiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The disabilities of the arm, shoulder and hand (DASH) questionnaire
Time Frame: 0-4 week
|
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.
The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
|
0-4 week
|
Visual Analogue Scale (VAS)
Time Frame: 0-4 week
|
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
|
0-4 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Michigan Hand Outcomes Questionnaire (MHQ)
Time Frame: 0-4 week
|
The MHQ is a patient-rated questionnaire, which means the patients evaluate their health state themselves.
It was developed using the psychometric principles for psychological assessments (Reliability, Validity, Standardization, and Freedom from bias).
The questionnaire consists of 37 items that can be grouped into six main categories (scored 0 (no disability) to 100).
Special to this assessment is the inclusion of items about aesthetics, which is often regarded as very important by patients, and the separate evaluation of the left and the right side.
These two categories are often overlooked in other similar assessments which might e.g.
focus more on the overall disability or pain experience.
The questions are directed towards patients' experiences with the hand/upper extremity during the past week.
|
0-4 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: İsmail Ceylan, PhD., Kirsehir Ahi Evran Universitesi
Publications and helpful links
General Publications
- Beselga C, Neto F, Alburquerque-Sendin F, Hall T, Oliveira-Campelo N. Immediate effects of hip mobilization with movement in patients with hip osteoarthritis: A randomised controlled trial. Man Ther. 2016 Apr;22:80-5. doi: 10.1016/j.math.2015.10.007. Epub 2015 Oct 31.
- Cruz-Diaz D, Lomas Vega R, Osuna-Perez MC, Hita-Contreras F, Martinez-Amat A. Effects of joint mobilization on chronic ankle instability: a randomized controlled trial. Disabil Rehabil. 2015;37(7):601-10. doi: 10.3109/09638288.2014.935877. Epub 2014 Jul 3.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1206845174
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.
Clinical Trials on Pain, Chronic
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Assiut UniversityNot yet recruiting
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Istanbul UniversityCompletedLow Back Pain, Mechanical, Biofeedback, Pain, Chronic
-
Apurano Pharmaceuticals GmbHRecruitingPain | Lower Back Pain | Back Pain | Chronic Pain | Pain, Chronic | Chronic Pain Syndrome | Pain Syndrome | Lower Back Pain ChronicGermany
Clinical Trials on TENS, US, exercise
-
October 6 UniversityCompletedCervicogenic HeadacheEgypt
-
Uşak UniversityCompleted
-
Balikesir UniversityCompletedAdhesive Capsulitis of Shoulder
-
Riphah International UniversityCompletedLumbar RadiculopathyPakistan
-
Nilay AralSante Medical CenterRecruitingKnee Osteoarthritis | Sensation DisordersTurkey
-
Prince Sattam Bin Abdulaziz UniversityCompleted
-
Ahi Evran University Education and Research HospitalCompletedPain | Acute Pain | Mobility LimitationTurkey
-
Arcadia UniversityCompleted
-
Glasgow Caledonian UniversityKing's College London; St George's, University of London; University of Glasgow; NHS LanarkshireRecruitingIntermittent Claudication | Peripheral Artery DiseaseUnited Kingdom