Cubital Tunnel SyndromeNCT07797023
Comparative Efficacy of Soft Tissue Mobilization and Ulnar Nerve-Specific Strengthening Exercises in Patients With Cubital Tunnel Syndrome
A study testing Soft Tissue Mobilization and Ulnar Nerve-Specific Strengthening and Nerve-Gliding Exercises in people with Cubital Tunnel Syndrome, run by Hamna Sarfraz at 1 site in Pakistan.
Trial summary
Cubital tunnel syndrome occurs when the ulnar nerve is compressed or irritated near the elbow. It can cause elbow or forearm pain, numbness or tingling in the ring and little fingers, hand weakness, and difficulty performing daily activities. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- Soft Tissue Mobilization and Ulnar Nerve-Specific Strengthening and Nerve-Gliding Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Oct 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with mild to moderate cubital tunnel syndrome (ulnar neuropathy at the elbow)
- Patients having symptoms for more than one month
- Patients who are willing to participate and provide informed consent.
- Patients who are able to follow instructions and complete the treatment protocol.
Who cannot join
- Patients with a history of elbow surgery
- Patients with severe neurological deficits (e.g., advanced muscle atrophy or complete nerve palsy)
- Patients with fracture or dislocation of the elbow joint
- Patients with systemic neurological disorders (e.g., stroke, multiple sclerosis)
- Patients with rheumatoid arthritis or other inflammatory joint diseases
- Patients currently receiving other physiotherapy or invasive treatments for the same condition.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Physiotherapy Departments of Nawaz Sharif Social Security Hospital, Multan Road, Lahore, and MoveNow Physiotherapy and Rehabilitation Centre, Lahore.
Lahore, 54000
About this study
Cubital tunnel syndrome occurs when the ulnar nerve is compressed or irritated near the elbow. It can cause elbow or forearm pain, numbness or tingling in the ring and little fingers, hand weakness, and difficulty performing daily activities.
This randomized clinical trial will compare two conservative physiotherapy programs for adults with mild to moderate cubital tunnel syndrome. A total of 56 participants will be assigned by computer-generated randomization to one of two groups. Group A will receive soft tissue mobilization combined with ulnar nerve-specific strengthening and nerve-gliding exercises. Group B will receive soft tissue mobilization alone. Both groups will also receive education about activity modification, ergonomic correction, and avoiding prolonged elbow bending.
Read more
Treatment will be provided three times per week for four weeks, for a total of 12 sessions. Participants will be assessed before treatment and at the end of the fourth week. The main outcomes will be pain intensity, measured using the Numeric Pain Rating Scale, and upper-limb disability, measured using the Disabilities of the Arm, Shoulder and Hand questionnaire.
The study aims to determine whether adding ulnar nerve-specific strengthening and nerve-gliding exercises to soft tissue mobilization provides greater improvement in pain and upper-limb function than soft tissue mobilization alone.
Read the detailed description
Cubital tunnel syndrome, also known as ulnar neuropathy at the elbow, is a peripheral nerve entrapment disorder caused by compression or irritation of the ulnar nerve as it passes through the cubital tunnel. Individuals with this condition may experience pain around the medial elbow, numbness or tingling in the ring and little fingers, reduced grip strength, hand weakness, and limitations in upper-limb activities. Conservative physiotherapy is commonly recommended for mild to moderate cases; however, evidence comparing specific combinations of manual therapy and exercise remains limited.
This study is a randomized controlled trial designed to compare soft tissue mobilization combined with ulnar nerve-specific strengthening and nerve-gliding exercises with soft tissue mobilization alone. The study will recruit 56 adults aged 30-55 years with mild to moderate cubital tunnel syndrome. Participants will be recruited from the Physiotherapy Departments of Nawaz Sharif Social Security Hospital, Multan Road, Lahore, and MoveNow Physiotherapy and Rehabilitation Centre, Lahore, Pakistan.
Eligible participants will provide written informed consent before enrollment. They will then be allocated in a 1:1 ratio to Group A or Group B using a computer-generated randomization sequence, with 28 participants assigned to each group. Outcome assessment will be conducted at baseline and immediately after completion of the four-week intervention.
All participants will receive education regarding activity modification, ergonomic correction, and avoidance of prolonged elbow flexion. Group A will receive soft tissue mobilization together with ulnar nerve-specific strengthening and nerve-gliding exercises. Soft tissue mobilization will be applied to the medial elbow and flexor-pronator muscle region and may include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. The strengthening component will target the wrist flexors, forearm stabilizers, intrinsic hand muscles, and grip musculature. Exercises will include resisted wrist flexion, hand-grip exercises, finger abduction and adduction, thumb opposition, and resisted finger flexion. Exercises will generally be completed in two to three sets of 10-15 repetitions. Controlled ulnar nerve-gliding exercises will be performed within a pain-free range. Participants in this group will also be advised to perform the prescribed strengthening and nerve-gliding exercises at home once daily.
Group B will receive soft tissue mobilization alone. Manual therapy will be applied to the medial elbow and flexor-pronator region using standardized techniques such as myofascial release, longitudinal mobilization, effleurage, and deep transverse friction massage. Participants in this group will not receive the ulnar nerve-specific strengthening or nerve-gliding program during the intervention period.
Both groups will attend three treatment sessions per week for four weeks, resulting in 12 sessions. Sessions will last approximately 30-40 minutes for Group A and 20-30 minutes for Group B.
Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale, ranging from 0, indicating no pain, to 10, indicating the worst possible pain. Upper-limb disability will be measured using the 30-item Disabilities of the Arm, Shoulder and Hand questionnaire, with scores ranging from 0, indicating no disability, to 100, indicating the greatest disability. The primary comparison will examine differences in changes in pain and upper-limb disability between baseline and the fourth week.
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- Soft Tissue Mobilization, Ulnar Nerve-Specific Strengthening and Nerve-Gliding Exercises
- Keywords
- Cubital Tunnel Syndrome, Disability Evaluation, Physical Therapy Modalities, Rehabilitation
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Tissue MobilizationOther
A physiotherapist will apply standardized manual soft tissue techniques to the medial elbow and flexor-pronator muscle region of the affected upper limb. Techniques will include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. The intervention is intended to reduce muscular and fascial restrictions, improve tissue extensibility and local circulation, and decrease mechanical irritation around the cubital tunnel. Treatment will be administered three times per week for four weeks, for a total of 12 sessions. This intervention will be provided to participants in both study arms.
Ulnar Nerve-Specific Strengthening and Nerve-Gliding ExercisesOther
Participants will perform progressive strengthening exercises targeting the wrist flexors, forearm stabilizers, intrinsic hand muscles, and grip musculature. Exercises will include resisted wrist flexion, hand-grip training, finger abduction and adduction, thumb opposition, and resisted finger flexion, generally performed in two to three sets of 10-15 repetitions. Controlled ulnar nerve-gliding exercises will also be performed within a pain-free range. Supervised treatment will be provided three times per week for four weeks, and participants will be instructed to complete the prescribed strengthening and nerve-gliding exercises at home once daily.
| Study group | Role | What they receive |
|---|---|---|
| Soft Tissue Mobilization Plus Ulnar Nerve-Specific Exercises | Experimental | Participants will receive soft tissue mobilization targeting the medial elbow and flexor-pronator muscles, combined with ulnar nerve-specific strengthening and nerve-gliding exercises. Manual techniques will include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. Strengthening will target the wrist flexors, forearm stabilizers, intrinsic hand muscles, and grip muscles. Participants will receive three sessions per week for four weeks (12 sessions), with each session lasting approximately 30-40 minutes. They will also receive activity-modification and ergonomic education and perform prescribed exercises at home once daily. Receives: Other: Ulnar Nerve-Specific Strengthening and Nerve-Gliding Exercises |
| Soft Tissue Mobilization Alone | Active comparator | Participants will receive standardized soft tissue mobilization targeting the medial elbow and flexor-pronator muscles. Techniques will include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. Participants will not receive ulnar nerve-specific strengthening or nerve-gliding exercises during the intervention period. Treatment will be provided three times per week for four weeks (12 sessions), with each session lasting approximately 20-30 minutes. Participants will also receive education regarding activity modification, ergonomic correction, and avoidance of prolonged elbow flexion. Receives: Other: Soft Tissue Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Measured by the Numeric Pain Rating Scale
Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS). Participants will rate their average pain during the previous 24 hours on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates the "worst possible pain." Lower scores represent less pain. Change will be calculated by comparing the baseline score with the score recorded after the four-week intervention.
Measured: Baseline and immediately after the 4-week intervention
Change in Upper-Limb Disability Measured by the Disabilities of the Arm, Shoulder and Hand Questionnaire
Upper-limb disability will be assessed using the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Items evaluate difficulty performing daily activities, symptom severity, and the effect of the condition on social and functional participation. The total score ranges from 0 to 100, where 0 indicates no disability and 100 indicates the greatest disability. Lower scores represent better upper-limb function. Change will be calculated by comparing baseline and post-intervention scores.
Measured: Baseline and immediately after the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start22 Oct 2025
- Primary completion14 Jun 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cubital Tunnel SyndromeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamna Sarfraz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hamna Sarfraz, University of Lahore
- Investigators
- Ahmed Umair, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797023
- Sponsor's protocol ID
- REHAB/04/26/MS/RS-4094
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolny T, Wieczorek M. Real Versus Sham-Based Neurodynamic Techniques in the Treatment of Cubital Tunnel Syndrome: A Randomized Placebo-Controlled Trial. J Clin Med. 2025 Mar 19;14(6):2096. doi: 10.3390/jcm14062096.
PubMed 40142903Deflorin C, Hohenauer E, Stoop R, van Daele U, Clijsen R, Taeymans J. Physical Management of Scar Tissue: A Systematic Review and Meta-Analysis. J Altern Complement Med. 2020 Oct;26(10):854-865. doi: 10.1089/acm.2020.0109. Epub 2020 Jun 24.
PubMed 32589450
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Soft Tissue Mobilization and Ulnar Nerve-Specific Strengthening Exercises in Patients With Cubital Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07797023
- Acronym / sponsor ID
- REHAB/04/26/MS/RS-4094
- Conditions
- Cubital Tunnel Syndrome
- Keywords
- Cubital Tunnel Syndrome, Disability Evaluation, Physical Therapy Modalities, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hamna SarfrazUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 14 Jun 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 1 Sep 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.
Cubital tunnel syndrome occurs when the ulnar nerve is compressed or irritated near the elbow. It can cause elbow or forearm pain, numbness or tingling in the ring and little fingers, hand weakness, and difficulty performing daily activities.
This randomized clinical trial will compare two conservative physiotherapy programs for adults with mild to moderate cubital tunnel syndrome. A total of 56 participants will be assigned by computer-generated randomization to one of two groups. Group A will receive soft tissue mobilization combined with ulnar nerve-specific strengthening and nerve-gliding exercises. Group B will receive soft tissue mobilization alone. Both groups will also receive education about activity modification, ergonomic correction, and avoiding prolonged elbow bending.
Treatment will be provided three times per week for four weeks, for a total of 12 sessions. Participants will be assessed before treatment and at the end of the fourth week. The main outcomes will be pain intensity, measured using the Numeric Pain Rating Scale, and upper-limb disability, measured using the Disabilities of the Arm, Shoulder and Hand questionnaire.
The study aims to determine whether adding ulnar nerve-specific strengthening and nerve-gliding exercises to soft tissue mobilization provides greater improvement in pain and upper-limb function than soft tissue mobilization alone.
Detailed description
Cubital tunnel syndrome, also known as ulnar neuropathy at the elbow, is a peripheral nerve entrapment disorder caused by compression or irritation of the ulnar nerve as it passes through the cubital tunnel. Individuals with this condition may experience pain around the medial elbow, numbness or tingling in the ring and little fingers, reduced grip strength, hand weakness, and limitations in upper-limb activities. Conservative physiotherapy is commonly recommended for mild to moderate cases; however, evidence comparing specific combinations of manual therapy and exercise remains limited.
This study is a randomized controlled trial designed to compare soft tissue mobilization combined with ulnar nerve-specific strengthening and nerve-gliding exercises with soft tissue mobilization alone. The study will recruit 56 adults aged 30-55 years with mild to moderate cubital tunnel syndrome. Participants will be recruited from the Physiotherapy Departments of Nawaz Sharif Social Security Hospital, Multan Road, Lahore, and MoveNow Physiotherapy and Rehabilitation Centre, Lahore, Pakistan.
Eligible participants will provide written informed consent before enrollment. They will then be allocated in a 1:1 ratio to Group A or Group B using a computer-generated randomization sequence, with 28 participants assigned to each group. Outcome assessment will be conducted at baseline and immediately after completion of the four-week intervention.
All participants will receive education regarding activity modification, ergonomic correction, and avoidance of prolonged elbow flexion. Group A will receive soft tissue mobilization together with ulnar nerve-specific strengthening and nerve-gliding exercises. Soft tissue mobilization will be applied to the medial elbow and flexor-pronator muscle region and may include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. The strengthening component will target the wrist flexors, forearm stabilizers, intrinsic hand muscles, and grip musculature. Exercises will include resisted wrist flexion, hand-grip exercises, finger abduction and adduction, thumb opposition, and resisted finger flexion. Exercises will generally be completed in two to three sets of 10-15 repetitions. Controlled ulnar nerve-gliding exercises will be performed within a pain-free range. Participants in this group will also be advised to perform the prescribed strengthening and nerve-gliding exercises at home once daily.
Group B will receive soft tissue mobilization alone. Manual therapy will be applied to the medial elbow and flexor-pronator region using standardized techniques such as myofascial release, longitudinal mobilization, effleurage, and deep transverse friction massage. Participants in this group will not receive the ulnar nerve-specific strengthening or nerve-gliding program during the intervention period.
Both groups will attend three treatment sessions per week for four weeks, resulting in 12 sessions. Sessions will last approximately 30-40 minutes for Group A and 20-30 minutes for Group B.
Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale, ranging from 0, indicating no pain, to 10, indicating the worst possible pain. Upper-limb disability will be measured using the 30-item Disabilities of the Arm, Shoulder and Hand questionnaire, with scores ranging from 0, indicating no disability, to 100, indicating the greatest disability. The primary comparison will examine differences in changes in pain and upper-limb disability between baseline and the fourth week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soft Tissue Mobilization Plus Ulnar Nerve-Specific Exercises | Experimental | Other: Ulnar Nerve-Specific Strengthening and Nerve-Gliding ExercisesParticipants will receive soft tissue mobilization targeting the medial elbow and flexor-pronator muscles, combined with ulnar nerve-specific strengthening and nerve-gliding exercises. Manual techniques will include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. Strengthening will target the wrist flexors, forearm stabilizers, intrinsic hand muscles, and grip muscles. Participants will receive three sessions per week for four weeks (12 sessions), with each session lasting approximately 30-40 minutes. They will also receive activity-modification and ergonomic education and perform prescribed exercises at home once daily. |
| Soft Tissue Mobilization Alone | Active comparator | Other: Soft Tissue MobilizationParticipants will receive standardized soft tissue mobilization targeting the medial elbow and flexor-pronator muscles. Techniques will include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. Participants will not receive ulnar nerve-specific strengthening or nerve-gliding exercises during the intervention period. Treatment will be provided three times per week for four weeks (12 sessions), with each session lasting approximately 20-30 minutes. Participants will also receive education regarding activity modification, ergonomic correction, and avoidance of prolonged elbow flexion. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients diagnosed with mild to moderate cubital tunnel syndrome (ulnar neuropathy at the elbow)
- Patients having symptoms for more than one month
- Patients who are willing to participate and provide informed consent.
- Patients who are able to follow instructions and complete the treatment protocol.
Key exclusion criteria (6 listed)
- Patients with a history of elbow surgery
- Patients with severe neurological deficits (e.g., advanced muscle atrophy or complete nerve palsy)
- Patients with fracture or dislocation of the elbow joint
- Patients with systemic neurological disorders (e.g., stroke, multiple sclerosis)
- Patients with rheumatoid arthritis or other inflammatory joint diseases
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 |
|---|---|---|
| Soft Tissue MobilizationA physiotherapist will apply standardized manual soft tissue techniques to the medial elbow and flexor-pronator muscle region of the affected upper limb. Techniques will include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. The intervention is intended to reduce muscular and fascial restrictions, improve tissue extensibility and local circulation, and decrease mechanical irritation around the cubital tunnel. Treatment will be administered three times per week for four weeks, for a total of 12 sessions. This intervention will be provided to participants in both study arms. | Other | Soft Tissue Mobilization Alone |
| Ulnar Nerve-Specific Strengthening and Nerve-Gliding ExercisesParticipants will perform progressive strengthening exercises targeting the wrist flexors, forearm stabilizers, intrinsic hand muscles, and grip musculature. Exercises will include resisted wrist flexion, hand-grip training, finger abduction and adduction, thumb opposition, and resisted finger flexion, generally performed in two to three sets of 10-15 repetitions. Controlled ulnar nerve-gliding exercises will also be performed within a pain-free range. Supervised treatment will be provided three times per week for four weeks, and participants will be instructed to complete the prescribed strengthening and nerve-gliding exercises at home once daily. | Other | Soft Tissue Mobilization Plus Ulnar Nerve-Specific Exercises |
Primary outcome
Change in Pain Intensity Measured by the Numeric Pain Rating Scale
Time frame: Baseline and immediately after the 4-week intervention
Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS). Participants will rate their average pain during the previous 24 hours on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates the "worst possible pain." Lower scores represent less pain. Change will be calculated by comparing the baseline score with the score recorded after the four-week intervention.
Change in Upper-Limb Disability Measured by the Disabilities of the Arm, Shoulder and Hand Questionnaire
Time frame: Baseline and immediately after the 4-week intervention
Upper-limb disability will be assessed using the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Items evaluate difficulty performing daily activities, symptom severity, and the effect of the condition on social and functional participation. The total score ranges from 0 to 100, where 0 indicates no disability and 100 indicates the greatest disability. Lower scores represent better upper-limb function. Change will be calculated by comparing baseline and post-intervention scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 40142903Wolny T, Wieczorek M. Real Versus Sham-Based Neurodynamic Techniques in the Treatment of Cubital Tunnel Syndrome: A Randomized Placebo-Controlled Trial. J Clin Med. 2025 Mar 19;14(6):2096. doi: 10.3390/jcm14062096.
- Background: PubMed 32589450Deflorin C, Hohenauer E, Stoop R, van Daele U, Clijsen R, Taeymans J. Physical Management of Scar Tissue: A Systematic Review and Meta-Analysis. J Altern Complement Med. 2020 Oct;26(10):854-865. doi: 10.1089/acm.2020.0109. Epub 2020 Jun 24.
- 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.
Ahmed Umair principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft Tissue Mobilization and Ulnar Nerve-Specific Strengthening and Nerve-Gliding Exercises in people with Cubital Tunnel Syndrome, run by Hamna Sarfraz 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 4 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Measured by the Numeric Pain Rating Scale (time frame: Baseline and immediately after the 4-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07797023, which also lists 2 linked publications.
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 4 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.