Clinical trial NCT05904561: Effect of Low Level Laser Therapy Versus Pulsed Ultrasound
Official title: Effect of Low Level Laser Therapy Versus Pulsed Ultrasound on Postpartum Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
POSTPARTUM CARPAL TUNNEL SYNDROME
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 48
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carpal tunnel syndrome (CTs), the most common entrapment neuropathy of the upper extremity, is caused by compression of the median nerve as it travels through the carpal tunnel.

CTs was clinically diagnosed in more than half of women (62%). Neurophysiological evaluation diagnosed that CTs in around half of women (43%) was positive in one hand at least, also, it was reported that about half of women with CTs during pregnancy still complained of CTs symptoms one year after delivery.

Detailed description: Carpal tunnel syndrome pain and discomfort during postpartum period may interfere with the mother ability to successfully breastfeed due to increased physical load on the mother's hands and repetitive need for flexion during breastfeeding and carrying of the baby.

Observation of peripheral oedema in about 80% of pregnant women, especially in the period of third trimester is common, it is due to hormonal changes that cause reduction of venous return, fluid retention which decrease the carpal tunnel diameter and increase compression of the median nerve. Also, increase production of relaxin hormone leads to relaxation of the transverse carpal ligament and flattening of it that increase compression of the median nerve.

Symptoms of CTs differ from tingling, numbness and palmar side pain in radial 3.5 fingers. Typically, at night, patients are awakened by a numb hand. Complaints like decrease in hand strength, difficulty of holding things and dropping are common. Sensory distribution, median nerve hypoesthesia, positive provocative tests and atrophy or weakness of the thenar muscles may be shown in physical examination.

Nerve conduction study (NCS) has been showed as the gold standard in the diagnosis of CTs since it provides information about the physiological health of median nerve over the carpal tunnel. NCS measures sensory and motor nerve action potential which determines the severity of nerve entrapment.

Conservative treatment of CTs includes; local steroid injection, non-steroidal anti-inflammatory drugs, splinting, modification of activity, physical therapy modalities like ultrasound, low level laser therapy and stretching exercises.

Low level Laser therapy (LLLT) has analgesic and anti- inflammatory effect. Also, LLL improves the metabolic processes and increases protein synthesis that improves blood flow, blood vessel health and cell regeneration.

Eligibility criteria: Inclusion Criteria:

1. Postpartum women with mild to moderate carpal tunnel syndrome will participate in this study.
2. Their ages will range from 25 to 35 years old.
3. Their BMI will be ranged from 25 to 30 Kg/m2.
4. The electrophysiological evidence of mild or moderate median nerve lesion at wrist (mild: sensory nerve conduction velocity slow on finger/wrist measurement, sensory nerve latency \>3.5 ms, normal terminal motor latency; moderate: sensory potential preserved with motor slowing, distal motor latency to abductor pollicis brevis (APB) \< 6.5 ms) (Bland, 2000 and Dumitru and Zwarts, 2002).
5. Positive phalen's test.
6. Positive tinel's test.
7. Unilateral or bilateral carpal tunnel affection will be included.

Exclusion Criteria:

1. History of brachial plexopathy or malignancy.
2. Radial, ulnar neuropathy, proximal median neuropathy or polyneuropathy.
3. Previous wrist surgery or steroid injection for carpal tunnel syndrome.
4. History of trauma, fracture, deformity or inflammation in the wrist, such as rheumatoid arthritis.
5. Coagulation abnormalities, pregnancy, fever and infections.
6. Skin disease and skin cancer.
7. Spots, birthmarks or tattoos over the work points.
8. Pacemaker and implementable medical devices.

Primary outcomes:
measure: Pain Intensity
timeFrame: From base line to 4 weeks from starting the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy - Cairo University
Study officials:
affiliation: Department of physical Therapy for Women's Health, Faculty of Physical Therapy Cairo University
name: Afaf Mohammed, Assist.Prof.
role: STUDY_CHAIR
References: