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NCT Number: NCT04969393

Effects of High Intensity Laser on Mechanical and Physiological Findings in Pregnant Women With Carpal Tunnel Syndrome

This study will propose a novel approach to treat pregnant women with mild to moderate carpal tunnel syndrome (CTS) using the recently introduced High intensity laser therapy with its deep penetration and high-power characteristics. It's hopeful that the results of this study can fill the gap of knowledge surrounding the conservative treatment options for CTS in order to help patients restore their nerve function properly and promote new ways of addressing CTS.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Pregnancy Related Sprains and Strains Wounds and Injuries

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October 6 University Hospital

Al Ḩayy Ath Thāmin, Giza Governorate, 12511, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(1) Pregnant women with mild to moderate CTS diagnosed by a physician according to the American Association of Electrodiagnostic recent guidelines [18] (2) The age ranged between 20 to 40 years (3) Had positive clinical provocative tests for the CTS (Tinel test and Phalen test) and (5) Had a history of pain, paresthesia or numbness in the median nerve distribution, nocturnal pain, and night waking

Exclusion criteria

Patients were excluded from the study if they had cervical disc prolapse, cervical spondylosis, thoracic outlet syndrome, diabetes, gestational diabetes, cardiovascular disorders and hypertension. Patients who had carpal tunnel release surgery and patients who were diagnosed with CTS before pregnancy were also excluded from the study.

Treatment and study plan

High intensity laser therapy

Device

Fifteen treatment sessions with pulsed Nd: YAG laser were applied to the subjects of the study group, three sessions per week, over 5 weeks in succession via EXAND MY 1064 nm Laser system, Mectronic Medicale, Italy. Patients in group (A) received HILT along with the conventional physical therapy program. The session involved 3 subphases: (1) The Initial phase "Analgesic phase", (2) In the intermediate phase "Trigger point phase"and (3)The final phase "Bio-stimulation phase" was applied for 6 minutes with a slow scanning in several parallel longitudinal lines.

Other names: High power laser therapy

Conventional physical therapy

Other

Fifteen treatment sessions that involved using a neutral custom volar splint alongside neural and tendon gliding exercises. the splint was used at night and while performing strenuous activities during the day for 5 weeks. While nerve and tendon gliding exercises was repeated 10 times at each session and patients were encouraged to apply exercise 3-5 times per day for 5 weeks.

Other names: Standard Physiotherapy

Primary outcomes

  1. Changes in Distal latency of median nerve sensory distal latency

    Time frame: Baseline and after 5 Weeks

    The Median sensory nerve (SNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.

  2. Changes in Distal latency of median nerve motor distal latency

    Time frame: Baseline and after 5 Weeks

    The Median motor nerve (MNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.

Secondary outcomes

  1. Changes in hand grip strength

    Time frame: Baseline and after 5 Weeks

    The hand grip strength (measured in Kilograms) was evaluated by the same investigator. Grip strength was tested by using Jamar hand held dynamometer following the American Society of Hand Therapists guidelines. The patient's arm was positioned with the shoulder adducted and neutrally rotated, the elbow was flexed at 90, the forearm and wrist were neutrally positioned while the participant was sitting. Patients were instructed to squeeze the handle as hard as they could, do maximal grip contraction for 2-5 s.

  2. Changes in numeric pain rating scale (NPRS)

    Time frame: Baseline and after 5 Weeks

    An 11-point Numerical Pain Rating Scale (NPRS; 0 = no pain, 10 = maximum pain) was used to assess the patients' levels of hand pain pre and post treatment.

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

Effects of High Intensity Laser on Mechanical and Physiological Findings in Pregnant Women With Carpal Tunnel Syndrome: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2021
Registry last updated
Sep 9, 2021

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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