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

NCT04969393 | Completed

• 1 other identifier: HILTPCTS2021
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Pregnancy Related

Keywords

carpal tunnel syndrome; high intensity laser therapy; electrophysiology; pregnant women

Outcome Measures

Primary Outcomes (2)

• Changes in Distal latency of median nerve sensory distal latency

  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.

  Baseline and after 5 Weeks

• Changes in Distal latency of median nerve motor distal latency

  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.

  Baseline and after 5 Weeks

Secondary Outcomes (2)

• Changes in hand grip strength

  Baseline and after 5 Weeks

• Changes in numeric pain rating scale (NPRS)

  Baseline and after 5 Weeks

Study Arms (2)

Group A (High Intensity Laser therapy + Conventional Physical Therapy)

EXPERIMENTAL

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; Other: Conventional Physical Therapy

Group B (Conventional Physical Therapy)

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: High power laser therapy

Group A (High Intensity Laser therapy + Conventional Physical 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.

Also known as: Standard Physiotherapy

Group A (High Intensity Laser therapy + Conventional Physical Therapy); Group B (Conventional Physical Therapy)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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

You may not qualify if:

• 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.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University Hospital

Al Ḩayy Ath Thāmin, Giza Governorate, 12511, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Abeer F Hanafy, Ph.D

  Cairo University

  STUDY CHAIR

• Radwa M Yehia, Ph.D

  Faculty of Physical Therapy, October 6 University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: April 30, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 Months after study publication
• Access Criteria: Email: mohamed.magdy.pt@o6u.edu.eg

Locations

EG (1)