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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04969393
• Other study ID #: HILTPCTS2021
• Status: Completed
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: September 2021
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Pregnancy Related
• Syndrome

Intervention

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:
• 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.

Locations

Country	Name	City	State
Egypt	October 6 University Hospital	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in hand grip strength	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.	Baseline and after 5 Weeks
Secondary	Changes in numeric pain rating scale (NPRS)	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.	Baseline and after 5 Weeks