NCT06598748

Brief Summary

The aim of this study is to find out the influence of mechanical interface mobilization technique which consists of 5 different steps, in management of carpal tunnel syndrome and how this technique effects pain and functional status in individuals who has carpal tunnel syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

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

December 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

April 29, 2024

Last Update Submit

September 16, 2024

Conditions

Keywords

CTS

Outcome Measures

Primary Outcomes (3)

  • Visual analogue scale (VAS)

    The VAS consists of a line, often 10 cm long, with verbal anchors at each end of the line, similar to a Numeric Rating Scale (i.e, no pain on the far left and severe pain on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.

    4 week (will be measured at the end of every week)]

  • Symptom Severity Scale

    Symptom Severity Scale (SSS) (24) The SSS consists of 11 items related to six domains said to be critical for the evaluation of CTS. Each item is rated by the patient on a 1-5 (most severe) Likert scale, with higher ratings indicating more pain and disability.

    1st week(pre) and 4th week(post)]

  • Hand functional status scale

    Hand functional status scale (FSS) (24) The FSS consists of eight-items related to a variety of activities commonly performed by a diverse of patients. Each item is rated by the patient on a 1-5 (most severe) Likert scale, with higher ratings indicating more pain and disability.

    1st week(pre) and 4th week(post)]

Study Arms (2)

Mechanical Interface Mobilisation Technique

EXPERIMENTAL

In the mechanical interface group, five techniques, including; wrist distraction (3 sets for 3 minutes), rhythmic and gentle stretching of the transverse carpal ligaments, release of palmar hand fascia, gliding of the finger flexor tendons (using oscillatory flexion-extension movement of metacarpophalangeal joint), and release of the upper forearm muscle and fascia will be applied. To release the upper forearm muscle as demonstrated for pronator teres muscle in, the therapist applied a firm pressure on the origin of the muscle by one thumb and concurrently moved the forearm into extension and supination (17).

Other: Mechanical Interface Mobilisation Technique

Exercise Therapy

ACTIVE COMPARATOR

Participants in this group will perform myofascial stretching of the carpal ligament, 3 days per week for four weeks along with isometric exercises at wrist joint as demonstrated by the physiotherapist. The participants will be instructed to perform gentle, pain-free isometrics of the wrist and hand musculature (25). Exercise would be performed with 5-10-second hold, with 10 repetitions (26).

Other: Exercise Therapy

Interventions

In the mechanical interface group, five techniques, including; wrist distraction (3 sets for 3 minutes), rhythmic and gentle stretching of the transverse carpal ligaments, release of palmar hand fascia, gliding of the finger flexor tendons (using oscillatory flexion-extension movement of metacarpophalangeal joint), and release of the upper forearm muscle and fascia will be applied. To release the upper forearm muscle as demonstrated for pronator teres muscle in, the therapist applied a firm pressure on the origin of the muscle by one thumb and concurrently moved the forearm into extension and supination (17).

Mechanical Interface Mobilisation Technique

Participants in this group will perform myofascial stretching of the carpal ligament, 3 days per week for four weeks along with isometric exercises at wrist joint as demonstrated by the physiotherapist. The participants will be instructed to perform gentle, pain-free isometrics of the wrist and hand musculature (25). Exercise would be performed with 5-10-second hold, with 10 repetitions (26).

Exercise Therapy

Eligibility Criteria

Age24 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive Phalen test and Tinel Test.
  • Positive symptoms of CTS (Pain, numbness, or tingling in the first three and lateral half of the fourth finger.

You may not qualify if:

  • No previous surgical treatments at the wrist joint, no fractures or open wounds at the wrist.
  • Patients with thoracic outlet syndrome, and cervical radiculopathy.
  • History of carpal tunnel release surgery.
  • Steroid injection in the carpal tunnel.
  • Pregnant females.
  • Metabolic diseases such as diabetes, severe thyroid disorders and anemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhqh Campus 2 Khushab

Khushāb, Punjab Province, 41000, Pakistan

Location

Related Publications (26)

  • Chammas M, Boretto J, Burmann LM, Ramos RM, Dos Santos Neto FC, Silva JB. Carpal tunnel syndrome - Part I (anatomy, physiology, etiology and diagnosis). Rev Bras Ortop. 2014 Aug 20;49(5):429-36. doi: 10.1016/j.rboe.2014.08.001. eCollection 2014 Sep-Oct.

    PMID: 26229841BACKGROUND
  • Michlovitz SL. Conservative interventions for carpal tunnel syndrome. J Orthop Sports Phys Ther. 2004 Oct;34(10):589-600. doi: 10.2519/jospt.2004.34.10.589.

    PMID: 15552705BACKGROUND
  • Rota E, Morelli N. Entrapment neuropathies in diabetes mellitus. World J Diabetes. 2016 Sep 15;7(17):342-53. doi: 10.4239/wjd.v7.i17.342.

    PMID: 27660694BACKGROUND
  • Naeser MA, Hahn KA, Lieberman BE, Branco KF. Carpal tunnel syndrome pain treated with low-level laser and microamperes transcutaneous electric nerve stimulation: A controlled study. Arch Phys Med Rehabil. 2002 Jul;83(7):978-88. doi: 10.1053/apmr.2002.33096.

    PMID: 12098159BACKGROUND
  • Bland JD. Treatment of carpal tunnel syndrome. Muscle Nerve. 2007 Aug;36(2):167-71. doi: 10.1002/mus.20802.

    PMID: 17534984BACKGROUND
  • Fernandez-de-Las Penas C, Ortega-Santiago R, de la Llave-Rincon AI, Martinez-Perez A, Fahandezh-Saddi Diaz H, Martinez-Martin J, Pareja JA, Cuadrado-Perez ML. Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: A Randomized Parallel-Group Trial. J Pain. 2015 Nov;16(11):1087-94. doi: 10.1016/j.jpain.2015.07.012. Epub 2015 Aug 15.

    PMID: 26281946BACKGROUND
  • Kanaan N, Sawaya RA. Carpal tunnel syndrome: modern diagnostic and management techniques. Br J Gen Pract. 2001 Apr;51(465):311-4.

    PMID: 11458486BACKGROUND
  • Zaralieva A, Georgiev GP, Karabinov V, Iliev A, Aleksiev A. Physical Therapy and Rehabilitation Approaches in Patients with Carpal Tunnel Syndrome. Cureus. 2020 Mar 3;12(3):e7171. doi: 10.7759/cureus.7171.

    PMID: 32257712BACKGROUND
  • Huisstede BM, Hoogvliet P, Randsdorp MS, Glerum S, van Middelkoop M, Koes BW. Carpal tunnel syndrome. Part I: effectiveness of nonsurgical treatments--a systematic review. Arch Phys Med Rehabil. 2010 Jul;91(7):981-1004. doi: 10.1016/j.apmr.2010.03.022.

    PMID: 20599038BACKGROUND
  • Jarvik JG, Comstock BA, Kliot M, Turner JA, Chan L, Heagerty PJ, Hollingworth W, Kerrigan CL, Deyo RA. Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial. Lancet. 2009 Sep 26;374(9695):1074-81. doi: 10.1016/S0140-6736(09)61517-8.

    PMID: 19782873BACKGROUND
  • Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.

    PMID: 19027342BACKGROUND
  • Nijs J, Van Houdenhove B, Oostendorp RA. Recognition of central sensitization in patients with musculoskeletal pain: Application of pain neurophysiology in manual therapy practice. Man Ther. 2010 Apr;15(2):135-41. doi: 10.1016/j.math.2009.12.001. Epub 2009 Dec 24.

    PMID: 20036180BACKGROUND
  • Lim YH, Chee DY, Girdler S, Lee HC. Median nerve mobilization techniques in the treatment of carpal tunnel syndrome: A systematic review. J Hand Ther. 2017 Oct-Dec;30(4):397-406. doi: 10.1016/j.jht.2017.06.019. Epub 2017 Jul 29.

    PMID: 28764878BACKGROUND
  • Medina McKeon JM, Yancosek KE. Neural gliding techniques for the treatment of carpal tunnel syndrome: a systematic review. J Sport Rehabil. 2008 Aug;17(3):324-41. doi: 10.1123/jsr.17.3.324.

    PMID: 18708684BACKGROUND
  • Burke J, Buchberger DJ, Carey-Loghmani MT, Dougherty PE, Greco DS, Dishman JD. A pilot study comparing two manual therapy interventions for carpal tunnel syndrome. J Manipulative Physiol Ther. 2007 Jan;30(1):50-61. doi: 10.1016/j.jmpt.2006.11.014.

    PMID: 17224356BACKGROUND
  • Talebi GA, Saadat P, Javadian Y, Taghipour M. Manual therapy in the treatment of carpal tunnel syndrome in diabetic patients: A randomized clinical trial. Caspian J Intern Med. 2018 Summer;9(3):283-289. doi: 10.22088/cjim.9.3.283.

    PMID: 30197774BACKGROUND
  • Talebi GA, Saadat P, Javadian Y, Taghipour M. Comparison of two manual therapy techniques in patients with carpal tunnel syndrome: A randomized clinical trial. Caspian J Intern Med. 2020;11(2):163-170. doi: 10.22088/cjim.11.2.163.

    PMID: 32509244BACKGROUND
  • Akalin E, El O, Peker O, Senocak O, Tamci S, Gulbahar S, Cakmur R, Oncel S. Treatment of carpal tunnel syndrome with nerve and tendon gliding exercises. Am J Phys Med Rehabil. 2002 Feb;81(2):108-13. doi: 10.1097/00002060-200202000-00006.

    PMID: 11807347BACKGROUND
  • Pinar L, Enhos A, Ada S, Gungor N. Can we use nerve gliding exercises in women with carpal tunnel syndrome? Adv Ther. 2005 Sep-Oct;22(5):467-75. doi: 10.1007/BF02849867.

    PMID: 16418156BACKGROUND
  • Seradge H, Jia YC, Owens W. In vivo measurement of carpal tunnel pressure in the functioning hand. J Hand Surg Am. 1995 Sep;20(5):855-9. doi: 10.1016/S0363-5023(05)80443-5.

    PMID: 8522756BACKGROUND
  • Sucher BM. Palpatory diagnosis and manipulative management of carpal tunnel syndrome. J Am Osteopath Assoc. 1994 Aug;94(8):647-63.

    PMID: 7960973BACKGROUND
  • Ghasemi-Rad M, Nosair E, Vegh A, Mohammadi A, Akkad A, Lesha E, Mohammadi MH, Sayed D, Davarian A, Maleki-Miyandoab T, Hasan A. A handy review of carpal tunnel syndrome: From anatomy to diagnosis and treatment. World J Radiol. 2014 Jun 28;6(6):284-300. doi: 10.4329/wjr.v6.i6.284.

    PMID: 24976931BACKGROUND
  • Oskouei AE, Talebi GA, Shakouri SK, Ghabili K. Effects of neuromobilization maneuver on clinical and electrophysiological measures of patients with carpal tunnel syndrome. J Phys Ther Sci. 2014 Jul;26(7):1017-22. doi: 10.1589/jpts.26.1017. Epub 2014 Jul 30.

    PMID: 25140086BACKGROUND
  • Leite JC, Jerosch-Herold C, Song F. A systematic review of the psychometric properties of the Boston Carpal Tunnel Questionnaire. BMC Musculoskelet Disord. 2006 Oct 20;7:78. doi: 10.1186/1471-2474-7-78.

    PMID: 17054773BACKGROUND
  • CAROLYN KISNER LACAJB. Therapeutic Exercises: Foundations and Techniques. 7th ed. Pine MADaJA, editor. Philadelphia PA, USA: F. A. Davis Company; 2018.

    BACKGROUND
  • McEvoy J, O'Sullivan K, Bron C. Therapeutic exercises for the shoulder region. Manual Therapy for Musculoskeletal Pain Syndromes: an evidence-and clinical-informed approach. 2015;373.

    BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Ramsha Tariq, MsOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The researchers who evaluated the participants were not informed of how the participants were grouped. Participants were informed that they would receive one of two different interventions without indicating which group should undergo mechanical interface mobilization technique or exercise therapy program.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to the experimental group or control group. Participants were not notified which group was assigned to
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

September 19, 2024

Study Start

December 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations