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Mobilization With Movement in Carpal Tunnel Syndrome.

Primary Purpose

Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TENS, US, exercise
Sponsored by
İSMAİL CEYLAN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic focused on measuring Pain, Mobilisation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kırşehir Ahi Evran Üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobilization with movement

Conventional

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The disabilities of the arm, shoulder and hand (DASH) questionnaire
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.
Visual Analogue Scale (VAS)
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.

Secondary Outcome Measures

The Michigan Hand Outcomes Questionnaire (MHQ)
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.

Full Information

First Posted
January 26, 2021
Last Updated
January 30, 2021
Sponsor
İSMAİL CEYLAN
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1. Study Identification

Unique Protocol Identification Number
NCT04733209
Brief Title
Mobilization With Movement in Carpal Tunnel Syndrome.
Official Title
Investigation of the Effectiveness of Movement With Mobilization Technique for Carpal Tunnel Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
December 28, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
İSMAİL CEYLAN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
Pain, Mobilisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobilization with movement
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
TENS, US, exercise
Intervention Description
Physiotherapy
Primary Outcome Measure Information:
Title
The disabilities of the arm, shoulder and hand (DASH) questionnaire
Description
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.
Time Frame
0-4 week
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
0-4 week
Secondary Outcome Measure Information:
Title
The Michigan Hand Outcomes Questionnaire (MHQ)
Description
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.
Time Frame
0-4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İsmail Ceylan, PhD.
Organizational Affiliation
Kirsehir Ahi Evran Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kırşehir Ahi Evran Üniversitesi
City
Kırşehir
State/Province
İç Anadolu
ZIP/Postal Code
40500
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26559319
Citation
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.
Results Reference
result
PubMed Identifier
24989067
Citation
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.
Results Reference
result
Links:
URL
https://bmulligan.com/
Description
The official international web site

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Mobilization With Movement in Carpal Tunnel Syndrome.

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