Temporomandibular Disorders (TMD)NCT07566936
Digital vs Conventional Stabilizing Splints in Temporomandibular Disorders
A study testing Conventional Stabilizing Splint and Digital Stabilizing Splint in people with Temporomandibular Disorders (TMD), run by Shifa Tameer-e-Millat University at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the clinical effectiveness of digitally fabricated and conventionally fabricated maxillary stabilization splints in patients diagnosed with Temporomandibular Disorders (TMD) according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- Conventional Stabilizing Splint and Digital Stabilizing Splint
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 26 Oct 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-40 years
- Diagnosis of Temporomandibular Disorder (TMD) according to standardized Diagnostic Criteria for Temporomandibular disorders Axis I
- Maximum unassisted mouth opening between 20-30 mm
- Symptoms present for ≥3 months (to exclude transient/self-limiting cases)
- Willingness to comply with study protocol and provide informed consent
Who cannot join
- Diagnosis of temporomandibular joint myalgia or Myofascial pain as the primary condition
- History of trauma to the temporomandibular joint or mandible
- Presence of degenerative joint diseases (e.g., osteoarthritis, rheumatoid arthritis)
- Congenital or developmental craniofacial anomalies affecting temporomandibular joint
- Prior temporomandibular joint surgery or ongoing orthodontic treatment
- Current use of: Analgesics, muscle relaxants, or anti-inflammatory drugs affecting temporomandibular joint symptoms
Show all 9Show fewer
- Prior Occlusal splint therapy within the last 3 months
- Systemic conditions affecting joint function (e.g., connective tissue disorders)
- Pregnancy or lactation (if intervention may influence compliance or physiology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial Comparing Digitally Fabricated and Conventional Stabilizing Splints in the Management of Temporomandibular Disorders
This randomized controlled trial aims to compare the clinical effectiveness of digitally fabricated and conventionally fabricated maxillary stabilization splints in patients diagnosed with Temporomandibular Disorders (TMD) according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
Participants will be randomly allocated in a 1:1 ratio to receive either a Digitally fabricated splint produced using computer-aided design and three-dimensional printing technology or a conventionally fabricated splint using standard impression and laboratory techniques.
Read more
The primary outcome is Change in Pain Intensity measured using the Characteristic Pain Intensity component of the Graded Chronic Pain Scale (GCPS), 0-100 scale. Higher scores indicate greater pain severity from baseline to 3 months as primary end point.
Secondary outcomes include change in pain-related disability assessed using the Graded Chronic Pain Scale (GCPS) disability score, change in maximum mouth opening measured in millimeters (mm), change in jaw functional limitation assessed using the Jaw Functional Limitation Scale (JFLS), resolution of temporomandibular joint (TMJ) clicking (present/absent), change in oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), and compliance with splint use measured as average nightly wear time (hours per night).
Assessments will be conducted at baseline and 3 months post-intervention. Outcome assessment will be performed by a blinded examiner.
Read the detailed description
This study is a parallel-group randomized controlled clinical trial designed to evaluate the effect of fabrication technique on the clinical performance of stabilization splints in patients with temporomandibular disorders (TMD). Eligible participants will be diagnosed according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I criteria. Following informed consent, participants will be randomly assigned in a 1:1 ratio to either the digitally fabricated splint group or the conventionally fabricated splint group using a computer-generated randomization sequence. Allocation concealment will be ensured by sequentially generated numbered, opaque, sealed envelopes prepared by an independent investigator.
For the digital workflow, maxillary and mandibular arches will be captured using an intra oral scanner. Splints will be designed using computer-aided design software and fabricated using additive manufacturing (three-dimensional printing) with biocompatible resin materials via digital light processing (DLP) technology. Post-processing will include cleaning and light curing according to standardized protocols.
For the conventional workflow, impressions will be obtained using elastomeric materials, followed by cast fabrication and articulation. Stabilization splints will be fabricated using heat-cured acrylic resin according to standardized laboratory procedures.
To ensure comparability between groups, splint design parameters will be standardized. All appliances will be maxillary full-coverage stabilization splints with even and simultaneous bilateral contacts in centric relation and canine-guided occlusion during excursive movements. Splint thickness will be standardized (approximately 2-3 mm), and all appliances will be adjusted intraorally at delivery to achieve uniform occlusal contacts.
Participants will be instructed to wear the splints nightly for a minimum of 8 hours. Clinical evaluations will be conducted at baseline and 3 months post-intervention. Outcome assessment will be performed by an examiner blinded to group allocation.
Data will be analyzed using IBM SPSS Statistics (version 26.0; IBM Corp., Armonk, NY, USA). A two-sided p-value < 0.05 will be considered statistically significant.. Normality will be assessed using the Shapiro-Wilk test. Between-group comparisons will be performed using independent t-tests or Mann-Whitney U tests, as appropriate. Within-group comparisons will be conducted using paired t-tests or Wilcoxon signed-rank tests. Repeated measures will be analyzed using repeated measures ANOVA or mixed-effects models.
This study is designed to isolate the effect of fabrication technique by controlling splint design variables while employing clinically relevant material systems, thereby providing evidence on the comparative effectiveness of digitally fabricated and conventionally fabricated stabilization splints in the management of temporomandibular disorders.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- Conventional Stabilizing Splint, Digital Stabilizing Splint
- Keywords
- Occlusal splints, stabilizing splints, Three dimensional Printing, Temporomandibular joint Disorder, Temporomandibular Disorders (TMD)
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Stabilizing SplintDevice
A conventional stabilizing splint is a removable dental appliance that fits over the upper or lower teeth. It is made using traditional laboratory methods from heat cure acrylic material based on a standard impression of the patient's teeth.
Digital Stabilizing SplintDevice
A digital stabilizing splint is a removable appliance that fits over the teeth and is made using digital scanning and three dimensional printing technology. A digital scan of the patient's teeth is used to design the splint on a computer, and it is then fabricated using three dimensional printing technology using a biocompatible material.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Stabilizing Splints Group | Active comparator | Participants allocated to this arm will receive conventionally fabricated maxillary stabilizing splints produced using traditional fabrication techniques. Maxillary and mandibular impressions will be obtained using elastomeric impression material, followed by cast fabrication in dental stone. Jaw relation will be recorded using a facebow transfer and centric relation registration. Splints will be fabricated on a semi-adjustable articulator using heat-cured acrylic resin. Occlusion will be adjusted to achieve even bilateral contacts in centric relation with canine-guided or mutually protected occlusion.
Participants will be instructed to wear the splint primarily during nighttime (minimum 8 hours daily). Necessary occlusal adjustments will be performed during follow-up visits. Receives: Device: Conventional Stabilizing Splint |
| Digital Stabilizing Splints Group | Experimental | Participants allocated to this arm will receive digitally fabricated maxillary stabilizing splints . Intra oral scanning will be performed to obtain digital impressions of both arches. Jaw relation will be recorded digitally transferred into the software. Splints will be designed using specialized Computer aided design software to ensure uniform thickness and precise occlusal contacts. Fabrication will be carried out using digital fabrication technology that is three dimensional printing with biocompatible resin material.
Post-insertion occlusal adjustments will be performed as needed to achieve even bilateral contacts in centric relation. Participants will be instructed to wear the splint primarily during nighttime (minimum 8 hours daily), similar to the conventional group. Receives: Device: Digital Stabilizing Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Change in Pain intensity will be assessed using the Characteristic Pain Intensity (CPI) component of the Graded Chronic Pain Scale (GCPS). The CPI is calculated based on patient-reported current, worst, and average pain scores and is expressed on a 0-100 scale, where higher scores indicate greater pain intensity.
The outcome measure is the mean change in CPI score from baseline to 3 months post-intervention.
Measured: Baseline to 3 months post-intervention
Secondary outcomes (6)
Change in Pain-Related Disability
Change in Pain-related disability will be assessed using the disability component of the Graded Chronic Pain Scale (GCPS), which includes three items evaluating interference with daily activities, social activities, and work, each scored on a 0-10 scale. The mean of these items is multiplied by 10 to generate a disability score ranging from 0 to 100, where higher scores indicate greater disability. The outcome measure is the mean change in disability score from baseline to 3 months post-intervention.
Measured: Baseline to 3 months post-intervention
Change in maximum mouth opening (MMO)
Maximum mouth opening will be measured as the maximum unassisted inter-incisal distance (in millimeters) using a calibrated ruler or digital caliper. Measurements will be obtained under standardized conditions at each assessment visit.
The outcome measure is the mean change in MMO (mm) from baseline to 3 months post-intervention, where higher values indicate improved mandibular function.
Measured: Baseline to 3 months post-intervention
Change in Jaw Functional Limitation
Functional limitation will be assessed using the Jaw Functional Limitation Scale (JFLS-20), a validated patient-reported outcome measure consisting of 20 items evaluating mastication, vertical jaw mobility, and emotional and verbal expression. Each item is scored on a 0-10 scale, and the total score is calculated as the mean of all items, resulting in a score ranging from 0 to 10, where higher scores indicate greater functional limitation.
The outcome measure is the mean change in JFLS-20 score from baseline to 3 months post-intervention.
Measured: Baseline to 3 months post-intervention
Resolution of Temporomandibular joint (TMJ) clicking
Resolution of TMJ clicking will be assessed clinically during mandibular opening and closing movements by a trained examiner under standardized conditions. Clicking will be recorded as a dichotomous variable (present/absent) based on the presence of an audible or palpable click during at least one of three consecutive mandibular opening-closing cycles.
The outcome measure is the proportion of participants demonstrating resolution of TMJ clicking (present at baseline and absent at 3 months post-intervention).
Measured: Baseline and 3 months post intervention
Change in oral health-related quality of life
Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14), a validated questionnaire consisting of 14 items evaluating functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Each item is scored on a 5-point Likert scale (0 = never to 4 = very often), with total scores ranging from 0 to 56, where higher scores indicate worse oral health-related quality of life.
The outcome measure is the mean change in OHIP-14 total score from baseline to 3 months post-intervention.
Measured: Baseline to 3 months post-intervention
Compliance with splint use
Compliance with splint use will be assessed based on patient-reported average nightly wear time (hours per night), recorded using a standardized daily log. Participants will document the number of hours the splint is worn each night throughout the study period.
The outcome measure is the mean average nightly wear time (hours/night) over the 3-month follow-up period.
Measured: From intervention (day of splint delivery) to 3 months post-intervention, with compliance recorded continuously and summarized as average nightly wear time at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 Jan 2026
- Primary completion26 Sep 2026 (estimated)
- Study completion26 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)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
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel groups receiving either digitally fabricated or conventionally fabricated maxillary stabilization splints. Both groups will be managed under standardized clinical protocols, with identical follow-up schedules and outcome assessment procedures. Clinical evaluations will be conducted at baseline, and 3 months post-intervention. Allocation will remain fixed throughout the study period, with no crossover between interventions. Outcome assessment will be performed by a blinded examiner.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Tameer-e-Millat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysha Sadaf, Shifa Tameer-e-Millat University
- Investigators
- Prof Anwar Ali Shah, BDS, PhD, M-Orth, FDSRCS, Study director, Shifa Tameer-e-Millat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566936
- Sponsor's protocol ID
- IRB 243-25
- Other IDs
- 053-2025
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study, including baseline characteristics, outcome measures, and relevant covariates, will be made available. The study protocol and statistical analysis plan will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Digitally Fabricated and Conventional Stabilizing Splints in the Management of Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT07566936
- Acronym / sponsor ID
- IRB 243-25
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- Occlusal splints, stabilizing splints, Three dimensional Printing, Temporomandibular joint Disorder, Temporomandibular Disorders (TMD)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shifa Tameer-e-Millat UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 26 Sep 2026 (estimated)
- Study completion
- 26 Oct 2026 (estimated)
- First posted
- 5 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.
This randomized controlled trial aims to compare the clinical effectiveness of digitally fabricated and conventionally fabricated maxillary stabilization splints in patients diagnosed with Temporomandibular Disorders (TMD) according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
Participants will be randomly allocated in a 1:1 ratio to receive either a Digitally fabricated splint produced using computer-aided design and three-dimensional printing technology or a conventionally fabricated splint using standard impression and laboratory techniques.
The primary outcome is Change in Pain Intensity measured using the Characteristic Pain Intensity component of the Graded Chronic Pain Scale (GCPS), 0-100 scale. Higher scores indicate greater pain severity from baseline to 3 months as primary end point.
Secondary outcomes include change in pain-related disability assessed using the Graded Chronic Pain Scale (GCPS) disability score, change in maximum mouth opening measured in millimeters (mm), change in jaw functional limitation assessed using the Jaw Functional Limitation Scale (JFLS), resolution of temporomandibular joint (TMJ) clicking (present/absent), change in oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), and compliance with splint use measured as average nightly wear time (hours per night).
Assessments will be conducted at baseline and 3 months post-intervention. Outcome assessment will be performed by a blinded examiner.
Detailed description
This study is a parallel-group randomized controlled clinical trial designed to evaluate the effect of fabrication technique on the clinical performance of stabilization splints in patients with temporomandibular disorders (TMD). Eligible participants will be diagnosed according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I criteria. Following informed consent, participants will be randomly assigned in a 1:1 ratio to either the digitally fabricated splint group or the conventionally fabricated splint group using a computer-generated randomization sequence. Allocation concealment will be ensured by sequentially generated numbered, opaque, sealed envelopes prepared by an independent investigator.
For the digital workflow, maxillary and mandibular arches will be captured using an intra oral scanner. Splints will be designed using computer-aided design software and fabricated using additive manufacturing (three-dimensional printing) with biocompatible resin materials via digital light processing (DLP) technology. Post-processing will include cleaning and light curing according to standardized protocols.
For the conventional workflow, impressions will be obtained using elastomeric materials, followed by cast fabrication and articulation. Stabilization splints will be fabricated using heat-cured acrylic resin according to standardized laboratory procedures.
To ensure comparability between groups, splint design parameters will be standardized. All appliances will be maxillary full-coverage stabilization splints with even and simultaneous bilateral contacts in centric relation and canine-guided occlusion during excursive movements. Splint thickness will be standardized (approximately 2-3 mm), and all appliances will be adjusted intraorally at delivery to achieve uniform occlusal contacts.
Participants will be instructed to wear the splints nightly for a minimum of 8 hours. Clinical evaluations will be conducted at baseline and 3 months post-intervention. Outcome assessment will be performed by an examiner blinded to group allocation.
Data will be analyzed using IBM SPSS Statistics (version 26.0; IBM Corp., Armonk, NY, USA). A two-sided p-value < 0.05 will be considered statistically significant.. Normality will be assessed using the Shapiro-Wilk test. Between-group comparisons will be performed using independent t-tests or Mann-Whitney U tests, as appropriate. Within-group comparisons will be conducted using paired t-tests or Wilcoxon signed-rank tests. Repeated measures will be analyzed using repeated measures ANOVA or mixed-effects models.
This study is designed to isolate the effect of fabrication technique by controlling splint design variables while employing clinically relevant material systems, thereby providing evidence on the comparative effectiveness of digitally fabricated and conventionally fabricated stabilization splints in the management of temporomandibular disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel groups receiving either digitally fabricated or conventionally fabricated maxillary stabilization splints. Both groups will be managed under standardized clinical protocols, with identical follow-up schedules and outcome assessment procedures. Clinical evaluations will be conducted at baseline, and 3 months post-intervention. Allocation will remain fixed throughout the study period, with no crossover between interventions. Outcome assessment will be performed by a blinded examiner.
| Arm | Type | Receives |
|---|---|---|
| Conventional Stabilizing Splints Group | Active comparator | Device: Conventional Stabilizing SplintParticipants allocated to this arm will receive conventionally fabricated maxillary stabilizing splints produced using traditional fabrication techniques. Maxillary and mandibular impressions will be obtained using elastomeric impression material, followed by cast fabrication in dental stone. Jaw relation will be recorded using a facebow transfer and centric relation registration. Splints will be fabricated on a semi-adjustable articulator using heat-cured acrylic resin. Occlusion will be adjusted to achieve even bilateral contacts in centric relation with canine-guided or mutually protected occlusion. Participants will be instructed to wear the splint primarily during nighttime (minimum 8 hours daily). Necessary occlusal adjustments will be performed during follow-up visits. |
| Digital Stabilizing Splints Group | Experimental | Device: Digital Stabilizing SplintParticipants allocated to this arm will receive digitally fabricated maxillary stabilizing splints . Intra oral scanning will be performed to obtain digital impressions of both arches. Jaw relation will be recorded digitally transferred into the software. Splints will be designed using specialized Computer aided design software to ensure uniform thickness and precise occlusal contacts. Fabrication will be carried out using digital fabrication technology that is three dimensional printing with biocompatible resin material. Post-insertion occlusal adjustments will be performed as needed to achieve even bilateral contacts in centric relation. Participants will be instructed to wear the splint primarily during nighttime (minimum 8 hours daily), similar to the conventional group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18-40 years
- Diagnosis of Temporomandibular Disorder (TMD) according to standardized Diagnostic Criteria for Temporomandibular disorders Axis I
- Maximum unassisted mouth opening between 20-30 mm
- Symptoms present for ≥3 months (to exclude transient/self-limiting cases)
- Willingness to comply with study protocol and provide informed consent
Key exclusion criteria (9 listed)
- Diagnosis of temporomandibular joint myalgia or Myofascial pain as the primary condition
- History of trauma to the temporomandibular joint or mandible
- Presence of degenerative joint diseases (e.g., osteoarthritis, rheumatoid arthritis)
- Congenital or developmental craniofacial anomalies affecting temporomandibular joint
- Prior temporomandibular joint surgery or ongoing orthodontic treatment
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 |
|---|---|---|
| Conventional Stabilizing SplintA conventional stabilizing splint is a removable dental appliance that fits over the upper or lower teeth. It is made using traditional laboratory methods from heat cure acrylic material based on a standard impression of the patient's teeth. | Device | Conventional Stabilizing Splints Group |
| Digital Stabilizing SplintA digital stabilizing splint is a removable appliance that fits over the teeth and is made using digital scanning and three dimensional printing technology. A digital scan of the patient's teeth is used to design the splint on a computer, and it is then fabricated using three dimensional printing technology using a biocompatible material. | Device | Digital Stabilizing Splints Group |
Primary outcome
Change in Pain Intensity
Time frame: Baseline to 3 months post-intervention
Change in Pain intensity will be assessed using the Characteristic Pain Intensity (CPI) component of the Graded Chronic Pain Scale (GCPS). The CPI is calculated based on patient-reported current, worst, and average pain scores and is expressed on a 0-100 scale, where higher scores indicate greater pain intensity. The outcome measure is the mean change in CPI score from baseline to 3 months post-intervention.
6 secondary outcomes
Change in Pain-Related Disability
Time frame: Baseline to 3 months post-intervention
Change in maximum mouth opening (MMO)
Time frame: Baseline to 3 months post-intervention
Change in Jaw Functional Limitation
Time frame: Baseline to 3 months post-intervention
Resolution of Temporomandibular joint (TMJ) clicking
Time frame: Baseline and 3 months post intervention
Change in oral health-related quality of life
Time frame: Baseline to 3 months post-intervention
Compliance with splint use
Time frame: From intervention (day of splint delivery) to 3 months post-intervention, with compliance recorded continuously and summarized as average nightly wear time at 3 months.
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 5 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this study, including baseline characteristics, outcome measures, and relevant covariates, will be made available. The study protocol and statistical analysis plan will also be shared.
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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.
Prof Anwar Ali Shah, BDS, PhD, M-Orth, FDSRCS study director
Shifa Tameer-e-Millat 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 Conventional Stabilizing Splint and Digital Stabilizing Splint in people with Temporomandibular Disorders (TMD), run by Shifa Tameer-e-Millat University 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 9 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: enrolling by invitation, as of the sponsor's last update on 5 May 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 (time frame: Baseline to 3 months post-intervention). 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 5 May 2026.