Sciatic RadiculopathyNCT06556823
Contralateral Leg Neuro-dynamic and Spine Mobilization With Leg Movement in Patients With Sciatica
A study testing CLNDT+ Conventional PT in Diabetic Population):, CLNDT+ Conventional PT in non Diabetic Population): and SMWLM+ Conventional PT in Diabetic Population) in people with Sciatic Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized clinical trial is to find the comparison of CLNDT and SMWLM technique in diabetic and non-diabetic sciatica patients on reducing back pain and improving range of motion of knee Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Sciatic Radiculopathy
- What is being tested?
- CLNDT+ Conventional PT in Diabetic Population):, CLNDT+ Conventional PT in non Diabetic Population): and SMWLM+ Conventional PT in Diabetic Population)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jul 2024to 10 Jan 2025
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having sciatica due to degenerative lumbar spine disorder confirm by Straight leg Rise test and Slump test.
- Patients having unilateral radiating leg pain
- Type 2 Diabetic population with past 3 years' history of Diabetes with HbA1c value 5.7% or above
Who cannot join
- Subject having bilateral leg pain or Cauda equina syndrome
- History of fracture at lumbar spine
- Patient having history of lumbar spine surgery or in symptomatic leg
- Subject having lower extremity vascular disease, Malignancy and pregnant female
- Participant having steroid therapy with in last 6 months.
- Subject having Hip pathologies like hip OA, tendinitis and Bursitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Contralateral Leg Neuro-dynamic Technique and Spine Mobilization With Leg Movement in Diabetic and Non-diabetic Patients With Sciatica
The aim of this randomized clinical trial is to find the comparison of CLNDT and SMWLM technique in diabetic and non-diabetic sciatica patients on reducing back pain and improving range of motion of knee
Read the detailed description
Sciatica is the broad term describe as radicular pain/ or paresthesia that originate from low back and radiate along sciatic nerve or with associated lumbosacral nerve root. Sciatica may occur unilaterally or bilaterally with or without lower extremity pain, People with sciatica describe sharp aching and radiating leg pain. It may cause neurological problem such as weakness, numbness or hypo-reflexes and in some cases bladder dysfunction may be present. Pain and discomfort in sciatica affect daily life activities such as walking, bending and running adversely which affect the quality of life.
Diabetes mellitus is a chronic hyperglycemic multisystem disorder which is characterized by either genetic or metabolic dysfunction. It is further classified into two categories type 1 diabetes mellitus (T1DM) which is genetic disorder that prevents the pancreatic beta cells to secrete insulin either due to destruction or reduced number of pancreatic beta cells and type 2 diabetes mellitus (T2DM) is a metabolic disorder in which peripheral insulin receptors of the body become resistant to insulin. The underlying pathophysiology of diabetes and lumbar spine disorders shows a strong association between lumbar degeneration and type 2 diabetes as there is increasing end product of toxic glycation, Expression of MMP-2 related to degradation of extracellular matrix and hyperglycemia induced inflammation of disc, although these changes were observed in animals as in human there is still some lacking about its pathophysiology.
Contralateral leg neuro-dynamic technique was introduced by Shacklock on Maitland concept of slump test that with in slump test position contralateral leg pain is reduced by maintaining this position. This technique is use to reduced pain and increase ROM in sciatica patients. Spinal Mobilization with leg movement was developed by Brain Mulligan, in this technique continuous lateral glides was applied on spinous process and performing actively or passively leg movement this technique is also use for sciatica patients to reduce pain and increase ROM.
The Rational of present study is to determine which technique CLNDT or SMWLM is more effective than other for Pain, ROM, and disability in diabetic and non- diabetic patients with sciatica. It will also determine effect of HbA1C level on pain, ROM and Disability on CLNDT and SMWLM techniques in Diabetic patients with sciatica
- Conditions
- Sciatic Radiculopathy
- Being tested
- CLNDT+ Conventional PT in Diabetic Population):, CLNDT+ Conventional PT in non Diabetic Population):, SMWLM+ Conventional PT in Diabetic Population), SMWLM+ Conventional PT in non Diabetic Population)
- Keywords
- Contralateral leg neuro-dynamic technique,, Spine mobilization with leg movement, Sciatica due to lumbar degenerative problems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLNDT+ Conventional PT in Diabetic Population):Other
The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).
CLNDT+ Conventional PT in non Diabetic Population):Other
The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).
SMWLM+ Conventional PT in Diabetic Population)Other
the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).
SMWLM+ Conventional PT in non Diabetic Population)Other
the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).
| Study group | Role | What they receive |
|---|---|---|
| Contralateral Leg Neuro Dynamic+ Conventional PT in Diabetic Population): | Experimental | The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set.
Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set). Receives: Other: CLNDT+ Conventional PT in Diabetic Population): |
| contralateral Leg Neuro Dynamic+ Conventional PT in non Diabetic Population): | Experimental | The patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Receives: Other: CLNDT+ Conventional PT in non Diabetic Population): |
| Spine Mobilization With Leg Movement+ Conventional PT in Diabetic Population) | Experimental | the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec.
Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set) Receives: Other: SMWLM+ Conventional PT in Diabetic Population) |
| Spine Mobilization With Leg Movement+ Conventional PT in non Diabetic Population) | Experimental | The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Receives: Other: SMWLM+ Conventional PT in non Diabetic Population) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer
It is a tool used to measure the range of motion of joint (0-180). Positioning plays a vital part in goniometry because it helps to place the joints in a zero starting or neutral position. The examiner stabilizes the proximal joint component and then carefully moves the distal component of the joint through its entire available range of motion until reaching the end feel. By using universal goniometer ROM of knee will be assessed, patient will be in supine lying with both legs on the table, fulcrum of goniometer will be aligned with lateral epicondyle while stationary arm is in align with lateral epicondyle and midline of femur. While moving arm is with lateral malleolus and fibula border, while maintaining same position flexion and extension will be performing and measure.
Measured: three weeks
Numeric Pain Rating Scale
The NPRS is an eleven-point pain impression scale: the patient rates pain from 0 (no aggravation) to 10 (most exceedingly terrible possible pain). Numeric Pain Rating Scale (NPRS), which was used to survey respondents' impression of the degree of pain that they felt. NPRS has been utilized in different examinations for low back pain.
Measured: three weeks
Modified Oswestry low back pain Disability Index
The Modified Oswestry Low back pain disability index is widely used standardized questionnaires used by health professional to evaluate patient disability level in patient with low back pain that how patients low back pain affect daily life activities. ODI consists of 10 different questions each score range from 0-5 from minimum to maximum. The score of each section is summed and then divided into total and multiply by 100.
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start3 Jul 2024
- Primary completion2 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatic RadiculopathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556823
- Sponsor's protocol ID
- REC 01864 Aiman Alam
- Status last verified
- Feb 2025
- First submitted
- 13 Aug 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Contralateral Leg Neuro-dynamic Technique and Spine Mobilization With Leg Movement in Diabetic and Non-diabetic Patients With Sciatica
- ClinicalTrials.gov ID
- NCT06556823
- Acronym / sponsor ID
- REC 01864 Aiman Alam
- Conditions
- Sciatic Radiculopathy
- Keywords
- Contralateral leg neuro-dynamic technique,, Spine mobilization with leg movement, Sciatica due to lumbar degenerative problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 16 Aug 2024 (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.
The aim of this randomized clinical trial is to find the comparison of CLNDT and SMWLM technique in diabetic and non-diabetic sciatica patients on reducing back pain and improving range of motion of knee
Detailed description
Sciatica is the broad term describe as radicular pain/ or paresthesia that originate from low back and radiate along sciatic nerve or with associated lumbosacral nerve root. Sciatica may occur unilaterally or bilaterally with or without lower extremity pain, People with sciatica describe sharp aching and radiating leg pain. It may cause neurological problem such as weakness, numbness or hypo-reflexes and in some cases bladder dysfunction may be present. Pain and discomfort in sciatica affect daily life activities such as walking, bending and running adversely which affect the quality of life.
Diabetes mellitus is a chronic hyperglycemic multisystem disorder which is characterized by either genetic or metabolic dysfunction. It is further classified into two categories type 1 diabetes mellitus (T1DM) which is genetic disorder that prevents the pancreatic beta cells to secrete insulin either due to destruction or reduced number of pancreatic beta cells and type 2 diabetes mellitus (T2DM) is a metabolic disorder in which peripheral insulin receptors of the body become resistant to insulin. The underlying pathophysiology of diabetes and lumbar spine disorders shows a strong association between lumbar degeneration and type 2 diabetes as there is increasing end product of toxic glycation, Expression of MMP-2 related to degradation of extracellular matrix and hyperglycemia induced inflammation of disc, although these changes were observed in animals as in human there is still some lacking about its pathophysiology.
Contralateral leg neuro-dynamic technique was introduced by Shacklock on Maitland concept of slump test that with in slump test position contralateral leg pain is reduced by maintaining this position. This technique is use to reduced pain and increase ROM in sciatica patients. Spinal Mobilization with leg movement was developed by Brain Mulligan, in this technique continuous lateral glides was applied on spinous process and performing actively or passively leg movement this technique is also use for sciatica patients to reduce pain and increase ROM.
The Rational of present study is to determine which technique CLNDT or SMWLM is more effective than other for Pain, ROM, and disability in diabetic and non- diabetic patients with sciatica. It will also determine effect of HbA1C level on pain, ROM and Disability on CLNDT and SMWLM techniques in Diabetic patients with sciatica
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Contralateral Leg Neuro Dynamic+ Conventional PT in Diabetic Population): | Experimental | Other: CLNDT+ Conventional PT in Diabetic Population):The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set). |
| contralateral Leg Neuro Dynamic+ Conventional PT in non Diabetic Population): | Experimental | Other: CLNDT+ Conventional PT in non Diabetic Population):The patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. |
| Spine Mobilization With Leg Movement+ Conventional PT in Diabetic Population) | Experimental | Other: SMWLM+ Conventional PT in Diabetic Population)the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set) |
| Spine Mobilization With Leg Movement+ Conventional PT in non Diabetic Population) | Experimental | Other: SMWLM+ Conventional PT in non Diabetic Population)The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients having sciatica due to degenerative lumbar spine disorder confirm by Straight leg Rise test and Slump test.
- Patients having unilateral radiating leg pain
- Type 2 Diabetic population with past 3 years' history of Diabetes with HbA1c value 5.7% or above
Key exclusion criteria (6 listed)
- Subject having bilateral leg pain or Cauda equina syndrome
- History of fracture at lumbar spine
- Patient having history of lumbar spine surgery or in symptomatic leg
- Subject having lower extremity vascular disease, Malignancy and pregnant female
- Participant having steroid therapy with in last 6 months.
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 |
|---|---|---|
| CLNDT+ Conventional PT in Diabetic Population):The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set). | Other | Contralateral Leg Neuro Dynamic+ Conventional PT in Diabetic Population): |
| CLNDT+ Conventional PT in non Diabetic Population):The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set). | Other | contralateral Leg Neuro Dynamic+ Conventional PT in non Diabetic Population): |
| SMWLM+ Conventional PT in Diabetic Population)the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set). | Other | Spine Mobilization With Leg Movement+ Conventional PT in Diabetic Population) |
| SMWLM+ Conventional PT in non Diabetic Population)the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set). | Other | Spine Mobilization With Leg Movement+ Conventional PT in non Diabetic Population) |
Primary outcome
Goniometer
Time frame: three weeks
It is a tool used to measure the range of motion of joint (0-180). Positioning plays a vital part in goniometry because it helps to place the joints in a zero starting or neutral position. The examiner stabilizes the proximal joint component and then carefully moves the distal component of the joint through its entire available range of motion until reaching the end feel. By using universal goniometer ROM of knee will be assessed, patient will be in supine lying with both legs on the table, fulcrum of goniometer will be aligned with lateral epicondyle while stationary arm is in align with lateral epicondyle and midline of femur. While moving arm is with lateral malleolus and fibula border, while maintaining same position flexion and extension will be performing and measure.
Numeric Pain Rating Scale
Time frame: three weeks
The NPRS is an eleven-point pain impression scale: the patient rates pain from 0 (no aggravation) to 10 (most exceedingly terrible possible pain). Numeric Pain Rating Scale (NPRS), which was used to survey respondents' impression of the degree of pain that they felt. NPRS has been utilized in different examinations for low back pain.
Modified Oswestry low back pain Disability Index
Time frame: three weeks
The Modified Oswestry Low back pain disability index is widely used standardized questionnaires used by health professional to evaluate patient disability level in patient with low back pain that how patients low back pain affect daily life activities. ODI consists of 10 different questions each score range from 0-5 from minimum to maximum. The score of each section is summed and then divided into total and multiply by 100.
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 21 Feb 2025.
- 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.
maria Khalid, MSOMPT 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 CLNDT+ Conventional PT in Diabetic Population):, CLNDT+ Conventional PT in non Diabetic Population): and SMWLM+ Conventional PT in Diabetic Population) in people with Sciatic Radiculopathy, run by Riphah International 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 3 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 21 Feb 2025. 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?
Goniometer (time frame: three weeks). 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?
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 21 Feb 2025.