NCT04733209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 26, 2021

Last Update Submit

January 30, 2021

Conditions

Keywords

PainMobilisation

Outcome Measures

Primary Outcomes (2)

  • 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.

    0-4 week

  • 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.

    0-4 week

Secondary Outcomes (1)

  • The Michigan Hand Outcomes Questionnaire (MHQ)

    0-4 week

Study Arms (2)

Mobilization with movement

EXPERIMENTAL

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.

Other: TENS, US, exercise

Conventional

ACTIVE COMPARATOR

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.

Other: TENS, US, exercise

Interventions

Physiotherapy

ConventionalMobilization with movement

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran Üniversitesi

Kırşehir, İç Anadolu, 40500, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • Ceylan I, Buyukturan O, Aykanat O, Buyukturan B, Sas S, Ceylan MF. The effectiveness of mobilization with movement on patients with mild and moderate carpal tunnel syndrome: A single-blinded, randomized controlled study. J Hand Ther. 2023 Oct-Dec;36(4):773-785. doi: 10.1016/j.jht.2023.02.004. Epub 2023 Aug 11.

Related Links

MeSH Terms

Conditions

Chronic PainPain

Interventions

Transcutaneous Electric Nerve StimulationExercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • İsmail Ceylan, PhD.

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of hand therapy clinic. PhD.

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 1, 2021

Study Start

October 28, 2020

Primary Completion

December 28, 2020

Study Completion

January 15, 2021

Last Updated

February 3, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations