ClinicalTrials.gg
CompletedNCT05904561Updated Aug 25, 2023

Effect of Low Level Laser Therapy Versus Pulsed Ultrasound

An interventional study of low level laser therapy in Carpal Tunnel Syndrome and POSTPARTUM CARPAL TUNNEL SYNDROME, sponsored by Egymedicalpedia. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-08-25.

Sponsored by Egymedicalpedia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
25 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Carpal Tunnel Syndrome
  • POSTPARTUM CARPAL TUNNEL SYNDROME
03

In context

Carpal Tunnel Syndrome

605 studies on the registry are indexed under Carpal Tunnel Syndrome; 138 are open to participants now.

This study's enrollment of 48 is below the median of 60 across 457 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Egymedicalpedia is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Group (A) (Study group A)

    It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive low level laser therapy, for 10 minutes, three times per week for 4 weeks (total of 12 sessions), in addition to wrist exercises and home advices.

    Radiation: low level laser therapy

  • Experimental
    Group (B) (study group B)

    It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive pulsed ultrasound therapy, for 10 minutes, three times per week for 4 weeks (total of 12 sessions), in addition to wrist exercises and home advices

    Radiation: low level laser therapy

  • Active comparator
    Group (C) (control):

    It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive wrist exercises (strengthening exercises for thenar muscles, wrist flexors. Extensors, grip strengthening, stretching, nerve glide, neurodynamic technique and tendon glide) for 15 minutes, three times per week for 4 weeks (total of 12 sessions) and home advices only.

    Radiation: low level laser therapy

Interventions

  • Radiationlow level laser therapy

    comparing between the effect of low level laser therapy (LLLT) and pulsed ultrasound on post-partum carpal tunnel syndrome. All interventions that were pre-specified to be administered as part of the protocol, even if a particular intervention is not "of interest

    Also known as: pulsed ultrasound waves

06

What researchers measure

Primary outcomes

  1. Pain Intensity

    measure pain intensity for each woman in all groups (A, B and C). The VAS is usually presented as a 10-cm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Its simplicity, reliability and validity, as well as its ratio scale properties make the VAS the optimal tool for describing pain intensity

    Time frame: From base line to 4 weeks from starting the treatment

07

Study locations

1 site
  • Faculty of Physical Therapy - Cairo University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2023 to primary completion in Aug 2023, 4 months.

Of 267 interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 27. This study's 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2023
First posted
Jun 15, 2023
StartActual
Apr 1, 2023
Primary completionActual
Aug 1, 2023
CompletionActual
Aug 20, 2023
Last update
Aug 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05904561
Lead sponsor
Egymedicalpedia
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Apr 1, 2023
Primary completion
Aug 1, 2023
Completion
Aug 20, 2023
Last update
Aug 25, 2023

Study contacts

Afaf Mohammed, Assist.Prof.
study chair · Department of physical Therapy for Women's Health, Faculty of Physical Therapy Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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