Restless Leg Syndrome (RLS)NCT07308080
Combined Effects of Near-Infrared Light and Vibration on Diabetic Patients With Restless Leg Syndrome
A study testing Near-Infrared Light Therapy, Vibration and Conventional Physical Therapy in people with Restless Leg Syndrome (RLS), run by Lahore University of Biological and Applied Sciences.
Trial summary
This Randomized Clinical Trial, titled "Combined Effects of Near-Infrared Light and Vibration on Pain, Sleep Quality and Symptom Severity in Diabetic Patients with Restless Leg Syndrome," aims to evaluate a non-pharmacological treatment for Restless Leg Syndrome (RLS) in diabetic patients. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Restless Leg Syndrome (RLS)
- What is being tested?
- Near-Infrared Light Therapy, Vibration and Conventional Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2025to May 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of age 50-65 years Both male and female patients with Type II diabetes Patients with a diagnosis of diabetes at least 6 months ago RLS (score of 11+ on the RLS scale) Patients meeting the four key RLS diagnosis criteria will be included in the study.
- Criterion is: Urge to move due to uncomfortable leg sensations, symptoms worsening at rest, symptoms relief with movement ,greater symptom severity in the evening or at night.
- Willingness to provide informed consent .
Who cannot join
- Patients using analgesics, psychiatric, or neurological medications. Patients with any malignancies, neurological, skeletal, or vascular disorders History of drug abuse. Ongoing RLS treatments (e.g. vibration therapy, massage). Severe cognitive impairment. Pregnancy or lactation. Conditions contraindicating NIR or vibration therapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combined Effects of Near-Infrared Light and Vibration on Pain, Sleep Quality and Symptoms Severity in Diabetic Patients With Restless Leg Syndrome
This Randomized Clinical Trial, titled "Combined Effects of Near-Infrared Light and Vibration on Pain, Sleep Quality and Symptom Severity in Diabetic Patients with Restless Leg Syndrome," aims to evaluate a non-pharmacological treatment for Restless Leg Syndrome (RLS) in diabetic patients. RLS is a neurological disorder causing an irresistible urge to move the legs, and its co-occurrence with diabetes significantly worsens symptoms, pain, and sleep quality. While both Near-Infrared (NIR) light therapy and vibration therapy have individually shown benefits, this study will investigate the potential synergistic effects of combining them. 42 diabetic patients with RLS (aged 50-65) will be randomly assigned to one of three groups for four weeks (3 sessions/week): Group A (Vibration + Conventional Stretching), Group B (NIR Light + Conventional Stretching), and Group C (Combined Vibration and NIR Light + Conventional Stretching). Outcomes will be measured at baseline, 4 weeks, and 6 weeks using the International Restless Leg Syndrome Rating Scale (IRLS), the Pittsburgh Sleep Quality Index (PSQI), and the Numeric Pain Rating Scale (NPRS). This research explores the synergistic effects of near-infrared light and vibration therapy on Restless Leg Syndrome (RLS) symptoms in diabetic patients, aiming to alleviate symptoms, improve sleep quality, and enhance overall well-being.
Read the detailed description
Restless Leg Syndrome (RLS) is a prevalent neurological sensorimotor disorder characterized by an uncontrollable urge to move the legs, often accompanied by uncomfortable sensations that worsen during rest and at night, leading to significant sleep disturbances and reduced quality of life. The condition is particularly common among individuals with diabetes, where peripheral neuropathy, poor glycemic control, and microvascular complications further exacerbate symptom severity. In Pakistan, evidence suggests a notably high prevalence of RLS in patients with type II diabetes, highlighting the clinical and public health importance of effective, context-specific management strategies. Although pharmacological treatments are commonly used, their side effects and limited long-term effectiveness emphasize the need for safe and sustainable non-pharmacological interventions.
Recent advances in physical therapy and rehabilitative care have increasingly focused on non-invasive sensory and neuromodulatory approaches to manage RLS symptoms. Near-infrared (NIR) light therapy and vibration therapy have independently demonstrated beneficial effects in reducing pain, improving peripheral circulation, decreasing symptom severity, and enhancing sleep quality in patients with RLS. However, existing studies are limited by small sample sizes, heterogeneous protocols, and a lack of long-term follow-up, particularly in diabetic populations. Importantly, despite encouraging individual results, the combined therapeutic effects of NIR light and vibration have not yet been systematically explored in diabetic patients with RLS, representing a significant gap in current rehabilitation research.
This randomized clinical trial aims to investigate the combined effects of near-infrared light and vibration therapy on pain intensity, sleep quality, and symptom severity in diabetic patients diagnosed with Restless Leg Syndrome. Participants meeting established diagnostic criteria will be recruited from multiple clinical settings and randomly allocated into three groups: vibration therapy with conventional stretching exercises, near-infrared light therapy with conventional stretching exercises, and a combined intervention group receiving both vibration and NIR therapy alongside conventional physiotherapy. Outcomes will be assessed at baseline, post-intervention, and follow-up using validated tools including the International Restless Legs Syndrome Rating Scale, Pittsburgh Sleep Quality Index, and Numeric Pain Rating Scale.
The findings of this study are expected to provide clinically meaningful evidence regarding the effectiveness of combined vibration and near-infrared light therapy as a non-pharmacological treatment approach for RLS in diabetic patients. By addressing pain, sleep disturbances, and symptom severity simultaneously, this combined intervention may offer a safer and more effective alternative to medication-dependent management. The results have the potential to inform clinical practice, support patient-centered rehabilitation strategies, and improve overall quality of life for individuals living with diabetes and Restless Leg Syndrome, particularly in resource-limited healthcare settings.
- Conditions
- Restless Leg Syndrome (RLS)
- Being tested
- Near-Infrared Light Therapy, Vibration, Conventional Physical Therapy
- Keywords
- RLS, Diabetic patient, Near-Infrared Light, Vibration, Pain, Sleep Quality
- Medical subject headings
- Restless Legs Syndrome, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared Light TherapyOther
The Near-infrared light therapy will be applied under the supervision of a qualified physiotherapist. Near-infrared light therapy involves the application of infrared lamps to the lower limbs to improve blood flow, reduce inflammation, and modulate neural activity associated with Restless Leg Syndrome symptoms. Participants in this group will receive NIR therapy for 10 minutes per session as part of the combined intervention. The intervention will be delivered three times per week for a total duration of 4 weeks.
VibrationOther
Vibration therapy will be delivered using a low-voltage vibration device applied to the calf muscles. The therapy is intended to stimulate sensory receptors, improve neuromuscular function, and reduce symptom severity. Participants will receive vibration therapy for 10 minutes per session. The intervention will be delivered three times per week for a total duration of 4 weeks.
Conventional Physical TherapyBehavioural
The stretching program will be 30 minutes long, starting with a 5-minute warm-up, followed by 20 minutes of stretching exercises. The exercises will include hip rotation, quadriceps stretch, knee to chest stretch, hamstring stretch, gluteal stretch, straight leg raise, and side-lying leg lift. Each stretch will be held for 5 seconds and repeated for 3 sets of 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Group A( Vibration Therapy + Conventional Physical Therapy) | Experimental | Participants allocated to this group will receive vibration therapy in addition to conventional physical therapy. Localized vibration will be applied to the calf muscles using a low-voltage vibration device for 10 minutes during supervised rehabilitation sessions. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen comprising a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down. Receives: Other: Vibration; Behavioral: Conventional Physical Therapy |
| Group B (Near-Infrared Light + Conventional Physical Therapy) | Experimental | Participants allocated to this group will receive near-infrared (NIR) light therapy in addition to conventional physiotherapy. Near-infrared light will be applied to the lower limbs for 10 minutes during supervised rehabilitation sessions using a standardized therapeutic device. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen consisting of a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down. Receives: Other: Near-Infrared Light Therapy; Behavioral: Conventional Physical Therapy |
| Group C ( (Infrared light + Vibration and Conventional Therapy) | Experimental | Participants allocated to this group will receive combined near-infrared (NIR) light therapy and vibration therapy in addition to conventional physiotherapy. Near-infrared light therapy will be applied to the lower limbs for 10 minutes using a standardized therapeutic device, followed by localized vibration therapy applied to the calf muscles for 10 minutes using a low-voltage vibration device during supervised rehabilitation sessions. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen consisting of a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down. Receives: Other: Near-Infrared Light Therapy; Other: Vibration; Behavioral: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Restless Legs Syndrome Rating Scale (IRLS)
Severity of Restless Leg Syndrome symptoms will be assessed using the International Restless Legs Syndrome Rating Scale (IRLS), a validated 10-item questionnaire designed to evaluate symptom severity and impact on daily life. Each item is scored on a 5-point Likert scale, with total scores ranging from 0 to 40, where higher scores indicate greater symptom severity. Improvement will be defined as a reduction in IRLS total scores following the intervention.
Measured: Baseline, at 4th week, after 6th week
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a standardized 19-item self-report questionnaire assessing sleep quality and disturbances over the previous month. The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Improvement will be defined as a reduction in PSQI global scores following the intervention period.
Measured: Baseline, at 4th week, after 6th week
Numeric Pain Rating Scale (NPRS)
Pain intensity associated with Restless Leg Syndrome will be evaluated using the Numeric Pain Rating Scale (NPRS). Participants will rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain). Improvement will be defined as a decrease in NPRS scores after completion of the intervention.
Measured: Baseline, at 4th week, after 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start14 Dec 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Restless Leg Syndrome (RLS)Studies of the same condition, open and under way.
- More trials run by Lahore University of Biological and Applied SciencesThe sponsor's other registered studies.
- 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
- After recruitment of participants into the study, they will be allocated to their respective group utilizing the online randomization tool.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308080
- Sponsor's protocol ID
- UBAS/ERB/FoRS/25/038
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ratnani G, Harjpal P. Advancements in Restless Leg Syndrome Management: A Review of Physiotherapeutic Modalities and Their Efficacy. Cureus. 2023 Oct 10;15(10):e46779. doi: 10.7759/cureus.46779. eCollection 2023 Oct.
PubMed 37954781Ning P, Mu X, Yang X, Li T, Xu Y. Prevalence of restless legs syndrome in people with diabetes mellitus: A pooling analysis of observational studies. EClinicalMedicine. 2022 Mar 24;46:101357. doi: 10.1016/j.eclinm.2022.101357. eCollection 2022 Apr.
PubMed 35345532Coban O, Un Yildirim N, Yasa ME, Sonkaya AR. Effects of Different Exercise Programs on Symptoms, Sleep, and Quality of Life in Patients with Primary Restless Legs Syndrome. Mov Disord Clin Pract. 2023 Jul 27;10(9):1349-1359. doi: 10.1002/mdc3.13833. eCollection 2023 Sep.
PubMed 37772295
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Near-Infrared Light and Vibration on Pain, Sleep Quality and Symptoms Severity in Diabetic Patients With Restless Leg Syndrome
- ClinicalTrials.gov ID
- NCT07308080
- Acronym / sponsor ID
- UBAS/ERB/FoRS/25/038
- Conditions
- Restless Leg Syndrome (RLS)
- Keywords
- RLS, Diabetic patient, Near-Infrared Light, Vibration, Pain, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 14 Dec 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 29 Dec 2025 (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 Clinical Trial, titled "Combined Effects of Near-Infrared Light and Vibration on Pain, Sleep Quality and Symptom Severity in Diabetic Patients with Restless Leg Syndrome," aims to evaluate a non-pharmacological treatment for Restless Leg Syndrome (RLS) in diabetic patients. RLS is a neurological disorder causing an irresistible urge to move the legs, and its co-occurrence with diabetes significantly worsens symptoms, pain, and sleep quality. While both Near-Infrared (NIR) light therapy and vibration therapy have individually shown benefits, this study will investigate the potential synergistic effects of combining them. 42 diabetic patients with RLS (aged 50-65) will be randomly assigned to one of three groups for four weeks (3 sessions/week): Group A (Vibration + Conventional Stretching), Group B (NIR Light + Conventional Stretching), and Group C (Combined Vibration and NIR Light + Conventional Stretching). Outcomes will be measured at baseline, 4 weeks, and 6 weeks using the International Restless Leg Syndrome Rating Scale (IRLS), the Pittsburgh Sleep Quality Index (PSQI), and the Numeric Pain Rating Scale (NPRS). This research explores the synergistic effects of near-infrared light and vibration therapy on Restless Leg Syndrome (RLS) symptoms in diabetic patients, aiming to alleviate symptoms, improve sleep quality, and enhance overall well-being.
Detailed description
Restless Leg Syndrome (RLS) is a prevalent neurological sensorimotor disorder characterized by an uncontrollable urge to move the legs, often accompanied by uncomfortable sensations that worsen during rest and at night, leading to significant sleep disturbances and reduced quality of life. The condition is particularly common among individuals with diabetes, where peripheral neuropathy, poor glycemic control, and microvascular complications further exacerbate symptom severity. In Pakistan, evidence suggests a notably high prevalence of RLS in patients with type II diabetes, highlighting the clinical and public health importance of effective, context-specific management strategies. Although pharmacological treatments are commonly used, their side effects and limited long-term effectiveness emphasize the need for safe and sustainable non-pharmacological interventions.
Recent advances in physical therapy and rehabilitative care have increasingly focused on non-invasive sensory and neuromodulatory approaches to manage RLS symptoms. Near-infrared (NIR) light therapy and vibration therapy have independently demonstrated beneficial effects in reducing pain, improving peripheral circulation, decreasing symptom severity, and enhancing sleep quality in patients with RLS. However, existing studies are limited by small sample sizes, heterogeneous protocols, and a lack of long-term follow-up, particularly in diabetic populations. Importantly, despite encouraging individual results, the combined therapeutic effects of NIR light and vibration have not yet been systematically explored in diabetic patients with RLS, representing a significant gap in current rehabilitation research.
This randomized clinical trial aims to investigate the combined effects of near-infrared light and vibration therapy on pain intensity, sleep quality, and symptom severity in diabetic patients diagnosed with Restless Leg Syndrome. Participants meeting established diagnostic criteria will be recruited from multiple clinical settings and randomly allocated into three groups: vibration therapy with conventional stretching exercises, near-infrared light therapy with conventional stretching exercises, and a combined intervention group receiving both vibration and NIR therapy alongside conventional physiotherapy. Outcomes will be assessed at baseline, post-intervention, and follow-up using validated tools including the International Restless Legs Syndrome Rating Scale, Pittsburgh Sleep Quality Index, and Numeric Pain Rating Scale.
The findings of this study are expected to provide clinically meaningful evidence regarding the effectiveness of combined vibration and near-infrared light therapy as a non-pharmacological treatment approach for RLS in diabetic patients. By addressing pain, sleep disturbances, and symptom severity simultaneously, this combined intervention may offer a safer and more effective alternative to medication-dependent management. The results have the potential to inform clinical practice, support patient-centered rehabilitation strategies, and improve overall quality of life for individuals living with diabetes and Restless Leg Syndrome, particularly in resource-limited healthcare settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- After recruitment of participants into the study, they will be allocated to their respective group utilizing the online randomization tool.
| Arm | Type | Receives |
|---|---|---|
| Group A( Vibration Therapy + Conventional Physical Therapy) | Experimental | Other: Vibration, Behavioral: Conventional Physical TherapyParticipants allocated to this group will receive vibration therapy in addition to conventional physical therapy. Localized vibration will be applied to the calf muscles using a low-voltage vibration device for 10 minutes during supervised rehabilitation sessions. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen comprising a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down. |
| Group B (Near-Infrared Light + Conventional Physical Therapy) | Experimental | Other: Near-Infrared Light Therapy, Behavioral: Conventional Physical TherapyParticipants allocated to this group will receive near-infrared (NIR) light therapy in addition to conventional physiotherapy. Near-infrared light will be applied to the lower limbs for 10 minutes during supervised rehabilitation sessions using a standardized therapeutic device. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen consisting of a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down. |
| Group C ( (Infrared light + Vibration and Conventional Therapy) | Experimental | Other: Near-Infrared Light Therapy, Other: Vibration, Behavioral: Conventional Physical TherapyParticipants allocated to this group will receive combined near-infrared (NIR) light therapy and vibration therapy in addition to conventional physiotherapy. Near-infrared light therapy will be applied to the lower limbs for 10 minutes using a standardized therapeutic device, followed by localized vibration therapy applied to the calf muscles for 10 minutes using a low-voltage vibration device during supervised rehabilitation sessions. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen consisting of a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of age 50-65 years Both male and female patients with Type II diabetes Patients with a diagnosis of diabetes at least 6 months ago RLS (score of 11+ on the RLS scale) Patients meeting the four key RLS diagnosis criteria will be included in the study.
- Criterion is: Urge to move due to uncomfortable leg sensations, symptoms worsening at rest, symptoms relief with movement ,greater symptom severity in the evening or at night.
- Willingness to provide informed consent .
Key exclusion criteria (1 listed)
- Patients using analgesics, psychiatric, or neurological medications. Patients with any malignancies, neurological, skeletal, or vascular disorders History of drug abuse. Ongoing RLS treatments (e.g. vibration therapy, massage). Severe cognitive impairment. Pregnancy or lactation. Conditions contraindicating NIR or vibration therapy
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 |
|---|---|---|
| Near-Infrared Light TherapyThe Near-infrared light therapy will be applied under the supervision of a qualified physiotherapist. Near-infrared light therapy involves the application of infrared lamps to the lower limbs to improve blood flow, reduce inflammation, and modulate neural activity associated with Restless Leg Syndrome symptoms. Participants in this group will receive NIR therapy for 10 minutes per session as part of the combined intervention. The intervention will be delivered three times per week for a total duration of 4 weeks. | Other | Group B (Near-Infrared Light + Conventional Physical Therapy), Group C ( (Infrared light + Vibration and Conventional Therapy) |
| VibrationVibration therapy will be delivered using a low-voltage vibration device applied to the calf muscles. The therapy is intended to stimulate sensory receptors, improve neuromuscular function, and reduce symptom severity. Participants will receive vibration therapy for 10 minutes per session. The intervention will be delivered three times per week for a total duration of 4 weeks. | Other | Group A( Vibration Therapy + Conventional Physical Therapy), Group C ( (Infrared light + Vibration and Conventional Therapy) |
| Conventional Physical TherapyThe stretching program will be 30 minutes long, starting with a 5-minute warm-up, followed by 20 minutes of stretching exercises. The exercises will include hip rotation, quadriceps stretch, knee to chest stretch, hamstring stretch, gluteal stretch, straight leg raise, and side-lying leg lift. Each stretch will be held for 5 seconds and repeated for 3 sets of 10 repetitions. | Behavioural | Group A( Vibration Therapy + Conventional Physical Therapy), Group B (Near-Infrared Light + Conventional Physical Therapy), Group C ( (Infrared light + Vibration and Conventional Therapy) |
Primary outcome
International Restless Legs Syndrome Rating Scale (IRLS)
Time frame: Baseline, at 4th week, after 6th week
Severity of Restless Leg Syndrome symptoms will be assessed using the International Restless Legs Syndrome Rating Scale (IRLS), a validated 10-item questionnaire designed to evaluate symptom severity and impact on daily life. Each item is scored on a 5-point Likert scale, with total scores ranging from 0 to 40, where higher scores indicate greater symptom severity. Improvement will be defined as a reduction in IRLS total scores following the intervention.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, at 4th week, after 6th week
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a standardized 19-item self-report questionnaire assessing sleep quality and disturbances over the previous month. The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Improvement will be defined as a reduction in PSQI global scores following the intervention period.
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, at 4th week, after 6th week
Pain intensity associated with Restless Leg Syndrome will be evaluated using the Numeric Pain Rating Scale (NPRS). Participants will rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain). Improvement will be defined as a decrease in NPRS scores after completion of the intervention.
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 29 Dec 2025.
- Results publication: PubMed 37954781Ratnani G, Harjpal P. Advancements in Restless Leg Syndrome Management: A Review of Physiotherapeutic Modalities and Their Efficacy. Cureus. 2023 Oct 10;15(10):e46779. doi: 10.7759/cureus.46779. eCollection 2023 Oct.
- Results publication: PubMed 35345532Ning P, Mu X, Yang X, Li T, Xu Y. Prevalence of restless legs syndrome in people with diabetes mellitus: A pooling analysis of observational studies. EClinicalMedicine. 2022 Mar 24;46:101357. doi: 10.1016/j.eclinm.2022.101357. eCollection 2022 Apr.
- Results publication: PubMed 37772295Coban O, Un Yildirim N, Yasa ME, Sonkaya AR. Effects of Different Exercise Programs on Symptoms, Sleep, and Quality of Life in Patients with Primary Restless Legs Syndrome. Mov Disord Clin Pract. 2023 Jul 27;10(9):1349-1359. doi: 10.1002/mdc3.13833. eCollection 2023 Sep.
- Individual participant dataSharing planned: No
Related trials for Restless Leg Syndrome (RLS)
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)
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.
Questions about this trial
What is this clinical trial studying?
A study testing Near-Infrared Light Therapy, Vibration and Conventional Physical Therapy in people with Restless Leg Syndrome (RLS), run by Lahore University of Biological and Applied Sciences.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ainon Saleem (+923208438852, ainonsaleem246@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Restless Legs Syndrome Rating Scale (IRLS) (time frame: Baseline, at 4th week, after 6th week). The study lists 3 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 NCT07308080, which also lists 3 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 29 Dec 2025.