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Completed

NCT Number: NCT06598748

Effect of Mechanical Interface Mobilization Technique on Pain and Functional Status in Carpal Tunnel Syndrome

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.

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Key information

Age range

24 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhqh Campus 2 Khushab

Khushāb, Punjab Province, 41000, Pakistan

About this study

The median nerve gets entrapped in the wrist, causing carpal tunnel syndrome (CTS), the most prevalent peripheral neuropathy in the upper limb. A number of clinical findings, such as sensory issues with the first three digits of the hand sensory distribution of the median nerve, a positive Phalen test, weakness and atrophy of the thenar muscle, and electrophysiological findings (prolonged motor and sensory distal latencies of the median nerve) are used to diagnose CTS . The most frequent occupational risk factors for CTS are repetitive wrist and finger motions or holding uncomfortable wrist positions for extended periods of time. Tenosynovitis of the finger flexors, a thicker transverse carpal ligament, a fracture or dislocation of the distal radius or lunate, rheumatoid arthritis, lipoma, diabetes, and hyperthyroidism are other non-occupational causes . A combination of techniques has been used in the studies of Seradge H. et al and Sucher Benjamin M. Et al which included mechanical interface and neuro-dynamics, but the isolated effects of each method is yet to be determined by further studies as their combined effects are more focused on in the current literature. And that leads to an unclear decision about, which group of manual therapy techniques has better effects on individuals suffering from CTS .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mechanical Interface Mobilisation Technique

Other

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).

Exercise therapy

Other

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).

Primary outcomes

  1. Visual analogue scale (VAS)

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

    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.

  2. Symptom Severity Scale

    Time frame: 1st week(pre) and 4th week(post)]

    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.

  3. Hand functional status scale

    Time frame: 1st week(pre) and 4th week(post)]

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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