Carpal Tunnel Syndrome (CTS)PREG-CTS-USGNCT07613476
Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain
A study testing Pregabalin Phonophoresis and Therapeutic Ultrasound in people with Carpal Tunnel Syndrome (CTS), run by University of Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Pregabalin Phonophoresis and Therapeutic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 19 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Faisalabad
Faisalābad, Punjab Province, 3800
About this study
Official title: Effect of Pregabalin Phonophoresis Therapy on Pain and Functional Outcomes in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Pregabalin Phonophoresis, Therapeutic Ultrasound
- Keywords
- Phonophoresis, Neuropathic Pain, Ultrasound Therapy, Therapeutic ultrasound, Ultrasound assisted Drug delivery, Pregabalin gel, Physiotherapy modalities, Topical gel for neuropathic pain, Carpel tunnel syndrome
- Medical subject headings
- Carpal Tunnel Syndrome, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin PhonophoresisOther
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.
Therapeutic UltrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin Phonophoresis Group | Experimental | Participants receive phonophoresis using a pregabalin-based gel combined with therapeutic ultrasound. Receives: Other: Pregabalin Phonophoresis |
| Conventional Ultrasound Group | Active comparator | Participants receive therapeutic ultrasound using a standard, non-medicated coupling gel. Receives: Device: Therapeutic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS)
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.
Measured: Baseline and at Week 4 (immediately after the final treatment session)
Secondary outcomes (1)
Change in Functional Status as Measured by the Boston Carpal Tunnel Questionnaire (BCTQ)
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.
Measured: Baseline and at Week 4 (immediately after the final treatment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jan 2026
- Primary completion19 Jul 2026 (estimated)
- Study completion19 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Muneeb Jafar, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613476
- Sponsor's protocol ID
- TUF/EIRB/ 198 /26
- Acronym
- PREG-CTS-USG
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pregabalin Phonophoresis Therapy on Pain and Functional Outcomes in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07613476
- Acronym / sponsor ID
- PREG-CTS-USG / TUF/EIRB/ 198 /26
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Phonophoresis, Neuropathic Pain, Ultrasound Therapy, Therapeutic ultrasound, Ultrasound assisted Drug delivery, Pregabalin gel, Physiotherapy modalities, Topical gel for neuropathic pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 19 Jul 2026 (estimated)
- Study completion
- 19 Jul 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin Phonophoresis Group | Experimental | Other: Pregabalin PhonophoresisParticipants receive phonophoresis using a pregabalin-based gel combined with therapeutic ultrasound. |
| Conventional Ultrasound Group | Active comparator | Device: Therapeutic UltrasoundParticipants receive therapeutic ultrasound using a standard, non-medicated coupling gel. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin PhonophoresisA 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. | Other | Pregabalin Phonophoresis Group |
| Therapeutic UltrasoundStandard 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. | Device | Conventional Ultrasound Group |
Primary outcome
Change in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS)
Time frame: 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.
1 secondary outcome
Change in Functional Status as Measured by the Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: Baseline and at Week 4 (immediately after the final treatment session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin Phonophoresis and Therapeutic Ultrasound in people with Carpal Tunnel Syndrome (CTS), run by University of Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS) (time frame: Baseline and at Week 4 (immediately after the final treatment session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.