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

Sponsor
October 6 University (Other)
Overall Status
Completed
CT.gov ID
NCT04969393
Collaborator
(none)
54
1
2
3
18.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High intensity laser therapy
  • Other: Conventional Physical Therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of High Intensity Laser on Mechanical and Physiological Findings in Pregnant Women With Carpal Tunnel Syndrome: A Randomized Controlled Trial
Actual Study Start Date :
Apr 30, 2021
Actual Primary Completion Date :
Jul 30, 2021
Actual Study Completion Date :
Jul 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A (High Intensity Laser therapy + Conventional Physical Therapy)

Patients in group (A) received conventional physical therapy program along with HILT. Patients received pulsed Nd: YAG laser treatment, produced by EXAND MY 1064 nm Laser system, Mectronic Medicale, Italy. The apparatus provided pulsed emission (1064 nm), very high peak power (3 kW), a high level of fluency (energy density; 360-1780 mJ/cm2).

Device: High intensity laser therapy
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
  • Other: Conventional Physical Therapy
    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
  • Active Comparator: Group B (Conventional Physical Therapy)

    Patients in this group received the conventional physical therapy program in the form of splinting, tendon and neural gliding exercises. Patients were instructed to wear a neutral custom volar splint at night and while performing strenuous activities during the day for 5 weeks.Also, the patients performed nerve-and tendon-gliding exercise under direct supervision of the therapist during the treatment sessions. Each exercise was repeated 10 times at each session and patients were encouraged to apply exercise 3-5 times per day for 5 weeks.

    Other: Conventional Physical Therapy
    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
  • Outcome Measures

    Primary Outcome Measures

    1. Changes in Distal latency of median nerve sensory distal latency [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 [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 Outcome Measures

    1. Changes in hand grip strength [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 October 6 University Hospital Al Ḩayy Ath Thāmin Giza Egypt 12511

    Sponsors and Collaborators

    • October 6 University

    Investigators

    • Study Chair: Abeer F Hanafy, Ph.D, Cairo University
    • Study Director: Radwa M Yehia, Ph.D, Faculty of Physical Therapy, October 6 University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Magdy Ali Hassan ElMeligie, Principal investigator, October 6 University
    ClinicalTrials.gov Identifier:
    NCT04969393
    Other Study ID Numbers:
    • HILTPCTS2021
    First Posted:
    Jul 20, 2021
    Last Update Posted:
    Sep 9, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mohamed Magdy Ali Hassan ElMeligie, Principal investigator, October 6 University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 9, 2021