Carpal Tunnel Syndrome (CTS)
Conditions
Keywords
Phonophoresis, Neuropathic Pain, Ultrasound Therapy, Therapeutic ultrasound, Ultrasound assisted Drug delivery, Pregabalin gel, Physiotherapy modalities, Topical gel for neuropathic pain, Carpel tunnel syndrome
Brief summary
Carpal tunnel syndrome (CTS) is a common condition caused by pressure on the median nerve in the wrist, leading to pain, numbness, and weakness in the hand. Oral medications for nerve pain can have significant side effects. This study tests a new, non-invasive approach. Pregabalin, a medication for neuropathic pain, will be mixed into a gel and delivered through the skin using therapeutic ultrasound, a method called phonophoresis. This avoids the digestive system and may reduce side effects. This randomized controlled trial will compare the effects of pregabalin phonophoresis against standard ultrasound therapy (without the drug) in 57 patients aged 20-40 with mild to moderate CTS. Treatments will occur 4 times per week for one month. Pain will be measured using the Numeric Pain Rating Scale, and hand function using the Boston Carpal Tunnel Questionnaire. The study aims to determine if pregabalin phonophoresis provides superior pain relief and functional improvement compared to ultrasound alone, offering a new, safe, and cost-effective physiotherapy treatment for CTS.
Detailed description
This is a multi-center, prospective, randomized, active-controlled, parallel-group trial. After providing informed consent and meeting the inclusion criteria (positive Phalen's/Tinel's sign, symptom duration \>3 months, age 20-40), participants will be randomized into two groups using a random number generator. Group A (Experimental) will receive pregabalin phonophoresis. A pregabalin gel will be applied to the affected wrist, followed by therapeutic ultrasound at 1 MHz frequency, 1.5 W/cm\^² intensity in circular motion for 5 minutes. Group B (Active Comparator) will receive the same ultrasound parameters applied with a plain, non-medicated gel. Treatment for both groups will be administered 4 sessions per week for 4 consecutive weeks (total 16 sessions). Outcome measures, including the NPRS and the BCTSQ, will be collected at baseline and after the final treatment session at week 4. Data will be analyzed using SPSS version 22.0, with an intention-to-treat analysis. A p-value \<0.05 will be considered statistically significant. The trial will be conducted at Madinah Teaching Hospital and Jafar Physiotherapy Center in Faisalabad, Pakistan.
Interventions
OTHERPregabalin Phonophoresis
A topical gel containing pregabalin is applied to the volar aspect of the wrist over the carpal tunnel. A therapeutic ultrasound head (1 MHz, 1.5 W/cm\^²) is then moved in a circular motion over the gel for a total of 5 minutes per session. The ultrasound facilitates the transdermal delivery of pregabalin. This is administered 4 times per week for 4 weeks.
DEVICETherapeutic Ultrasound
Standard ultrasonic coupling gel is applied to the volar aspect of the wrist over the carpal tunnel. A therapeutic ultrasound head (1 MHz, 1.5 W/cm\^²) is then moved in a circular motion over the gel for a total of 5 minutes per session. This is administered 4 times per week for 4 weeks.
Sponsors
University of Faisalabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patient won't know if the gel contains the drug. The person measuring the final NRS and BCTSQ scores won't know which group the patient was in. The physician applying the treatment will know, but that's unavoidable.
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Carpal Tunnel Syndrome confirmed by positive Phalen's maneuver or Tinel's sign * Age between 20 and 40 years with no painkillers for more than a week * Symptom duration of more than 3 months * Mild to moderate CTS (no thenar muscle atrophy) * Willing to provide written informed consent
Exclusion criteria
* History of steroid injection for CTS in the past 3 months * Prior surgery for Carpal Tunnel Syndrome * Currently pregnant or breastfeeding * Malignancy or any contraindication to ultrasound (e.g., acute infection, bleeding disorder over the wrist) * Presence of cervical radiculopathy * Previous wrist fracture on the affected side * Participation in another interventional trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS) | Baseline and at Week 4 (immediately after the final treatment session) | The Numeric Pain Rating Scale (NPRS) is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will self-report their current level of pain. A higher score indicates worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Status as Measured by the Boston Carpal Tunnel Questionnaire (BCTQ) | Baseline and at Week 4 (immediately after the final treatment session) | The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific, patient-reported outcome measure. It consists of the Symptom Severity Scale (11 questions, each scored 1-5) and the Functional Status Scale (8 questions, each scored 1-5). The final score for each scale is the mean of the answers, ranging from 1 (best) to 5 (worst). A higher score indicates greater disability. |
Countries
Pakistan
Outcome results
None listed