Hamstring TightnessNCT06751160
Comparative Effects of Dry Needling Versus Soft Tissue Mobilization on Hamstring Tightness
A study testing Dry Needling and Soft Tissue Mobilization in people with Hamstring Tightness and Chronic Low-back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The hamstring tightness is considered as the inability to achieve knee extension greater than 160 degrees while hip is flexed at 90 degrees. When low back pain (LBP) persists for 12 weeks or longer, it is termed as chronic low back pain. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Hamstring Tightness, Chronic Low-back Pain
- What is being tested?
- Dry Needling and Soft Tissue Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Reduction in active knee extension test >25
- Current back pain between 4 to 6 on Numeric Pain Rating scale
- Low back pain for at least 12weeks0r 6 months
Who cannot join
- Subjects using anticoagulants and having vascular diseases
- Subjects with needle phobia and allergic to metals
- Subjects with cognitive impairment
- History of fracture in lumbar region
- History of systemic diseases e.g. cancer or systemic joint pathologies
- History of congestive heart failure in past 24 months
- Subjects have used medications like narcotics or Muscle relaxants 30 days before enrolment into study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Hameed Latif Medical Centre
Lahore, Punjab Province, 54000
About this study
Official title: Comparative Effects of Dry Needling Versus Soft Tissue Mobilization on Hamstring Tightness in Chronic Low Back Pain
The hamstring tightness is considered as the inability to achieve knee extension greater than 160 degrees while hip is flexed at 90 degrees. When low back pain (LBP) persists for 12 weeks or longer, it is termed as chronic low back pain. The objective of study is to see the effect of dry needling versus soft tissue mobilization on hamstring muscle on pain, range of motion and functionality in patients with chronic low back pain.
Read the detailed description
A randomized clinical trial will be conducted at Hameed Latif Medical Centre through non probability convenient sampling technique on 30 subjects which will be divided into two groups' 15 subjects in group A and 15 subjects in group B through computer generated software for Randomization. Both groups will be conventional therapy and spinal mobilization (posterior anterior glide) of grade 1 and 2 (3 sets of 6 repetitions) as baseline treatment. Group A was will be dry needling and Group B will be Soft Tissue Mobilization.
- Conditions
- Hamstring Tightness, Chronic Low-back Pain
- Being tested
- Dry Needling, Soft Tissue Mobilization
- Keywords
- Chronic Low Back Pain, Disability, Dry Needling, Hamstring Tightness, Soft Tissue Mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
Also called Group A
Baseline Treatment: Hot pack will be applied for 15 minutes on Hamstrings and lower back and transcutaneous electrical nerve stimulation (TENS) at lower back for warm up and pain relief to both groups. Then spinal mobilization (Poster lateral glide) of grade 1 and 2 (3 sets of 6 repetitions) i.e. within the spine resistance.
Dry Needling will be given to group A along with baseline treatment through following protocol:
Patient will be in prone lying. Sterilized disposable dry needles of 0.25*60mm will be used. Dry needling will be performed on three points on Hamstring muscle for one minute each. We considered a line between ischial tuberosity and head of fibula to target long head of bicep femoris (60% of line) and short head of bicep femoris (30% of line). Semitendinosus and Semi Membranosus were targeted at a point of 60% of line from ischial tuberosity to medial epicondyl of femur.
Sessions: Total 8 sessions will be given 2 sessions per week for 4 weeks.
Soft Tissue MobilizationOther
Also called Group B
Baseline Treatment: Hot pack will be applied for 15 minutes on Hamstrings and lower back and transcutaneous electrical nerve stimulation (TENS) at lower back for warm up and pain relief to both groups. Then spinal mobilization (Poster lateral glide) of grade 1 and 2 (3 sets of 6 repetitions) i.e. within the spine resistance.
Soft Tissue Mobilization will be given to Group B along with Baseline treatment.
Subject will be in prone lying position with knee bent at 30 to 60 degrees. Soft tissue mobilization will be applied on hamstring muscle through Graston technique. Massage cream will be applied on hamstring muscle and Graston Instrument will be rubbed from gluteal line to politeal fossa 30 times for 60 seconds.
Sessions: Total 8 sessions will be given 2 sessions per week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | Dry Needling along with baseline treatment Receives: Other: Dry Needling |
| Soft Tissue Mobilization | Experimental | Soft Tissue Mobilization along with baseline treatment Receives: Other: Soft Tissue Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Numeric Pain Rating Scale (NPRS) was used to measure low back pain. NPRS consists of 11 points, which range from 0= no pain, 1-4= mild pain, 4-7= moderate pain 7-10= severe pain . Researchers states that NPRS shows High test to re test reliability (ICC 0.96) in elderly populations with musculoskeletal disorders without having cognitive dysfunction.
Measured: 4 weeks
Oswestry Disability index (Urdu)
The Oswestry Disability index (ODI) consists of 10 patient- completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).
Measured: 4 weeks
Inclinometer
It was used to measure range of motion of low back. An instrument for measuring angles is an inclinometer. A sensor is housed in the housing of an inclinometer. The sensor measures the housing's tilt and is sensitive to gravity. After that, the angle is shown on a dial or digital display.
Measured: 4 weeks
Active Knee Extension Test
The most effective way to exclude the hamstring muscle's extensibility range, with the hip fixed at a 90-degree angle and precise instrument placement, is to perform the active knee extension test. This technique provides accurate measures of hamstring length and extensibility when used in a supine 90/90 position. Both a normal goniometer and an electrogoniometer were used to measure the amount of extension. Whether hamstring tightness contributes to mechanical low back pain can be inferred from this result.
Measured: 4 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start15 Jul 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring TightnessStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Raza, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751160
- Sponsor's protocol ID
- REC/RCR&AHS/24/0106
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Dry Needling Versus Soft Tissue Mobilization on Hamstring Tightness in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06751160
- Acronym / sponsor ID
- REC/RCR&AHS/24/0106
- Conditions
- Hamstring Tightness, Chronic Low-back Pain
- Keywords
- Chronic Low Back Pain, Disability, Dry Needling, Hamstring Tightness, Soft Tissue Mobilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 27 Dec 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 hamstring tightness is considered as the inability to achieve knee extension greater than 160 degrees while hip is flexed at 90 degrees. When low back pain (LBP) persists for 12 weeks or longer, it is termed as chronic low back pain. The objective of study is to see the effect of dry needling versus soft tissue mobilization on hamstring muscle on pain, range of motion and functionality in patients with chronic low back pain.
Detailed description
A randomized clinical trial will be conducted at Hameed Latif Medical Centre through non probability convenient sampling technique on 30 subjects which will be divided into two groups' 15 subjects in group A and 15 subjects in group B through computer generated software for Randomization. Both groups will be conventional therapy and spinal mobilization (posterior anterior glide) of grade 1 and 2 (3 sets of 6 repetitions) as baseline treatment. Group A was will be dry needling and Group B will be Soft Tissue Mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Other: Dry NeedlingDry Needling along with baseline treatment |
| Soft Tissue Mobilization | Experimental | Other: Soft Tissue MobilizationSoft Tissue Mobilization along with baseline treatment |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Reduction in active knee extension test >25
- Current back pain between 4 to 6 on Numeric Pain Rating scale
- Low back pain for at least 12weeks0r 6 months
Key exclusion criteria (7 listed)
- Subjects using anticoagulants and having vascular diseases
- Subjects with needle phobia and allergic to metals
- Subjects with cognitive impairment
- History of fracture in lumbar region
- History of systemic diseases e.g. cancer or systemic joint pathologies
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 |
|---|---|---|
| Dry NeedlingAlso: Group ABaseline Treatment: Hot pack will be applied for 15 minutes on Hamstrings and lower back and transcutaneous electrical nerve stimulation (TENS) at lower back for warm up and pain relief to both groups. Then spinal mobilization (Poster lateral glide) of grade 1 and 2 (3 sets of 6 repetitions) i.e. within the spine resistance. Dry Needling will be given to group A along with baseline treatment through following protocol: Patient will be in prone lying. Sterilized disposable dry needles of 0.25*60mm will be used. Dry needling will be performed on three points on Hamstring muscle for one minute each. We considered a line between ischial tuberosity and head of fibula to target long head of bicep femoris (60% of line) and short head of bicep femoris (30% of line). Semitendinosus and Semi Membranosus were targeted at a point of 60% of line from ischial tuberosity to medial epicondyl of femur. Sessions: Total 8 sessions will be given 2 sessions per week for 4 weeks. | Other | Dry Needling |
| Soft Tissue MobilizationAlso: Group BBaseline Treatment: Hot pack will be applied for 15 minutes on Hamstrings and lower back and transcutaneous electrical nerve stimulation (TENS) at lower back for warm up and pain relief to both groups. Then spinal mobilization (Poster lateral glide) of grade 1 and 2 (3 sets of 6 repetitions) i.e. within the spine resistance. Soft Tissue Mobilization will be given to Group B along with Baseline treatment. Subject will be in prone lying position with knee bent at 30 to 60 degrees. Soft tissue mobilization will be applied on hamstring muscle through Graston technique. Massage cream will be applied on hamstring muscle and Graston Instrument will be rubbed from gluteal line to politeal fossa 30 times for 60 seconds. Sessions: Total 8 sessions will be given 2 sessions per week for 4 weeks. | Other | Soft Tissue Mobilization |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4 weeks
Numeric Pain Rating Scale (NPRS) was used to measure low back pain. NPRS consists of 11 points, which range from 0= no pain, 1-4= mild pain, 4-7= moderate pain 7-10= severe pain . Researchers states that NPRS shows High test to re test reliability (ICC 0.96) in elderly populations with musculoskeletal disorders without having cognitive dysfunction.
Oswestry Disability index (Urdu)
Time frame: 4 weeks
The Oswestry Disability index (ODI) consists of 10 patient- completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).
Inclinometer
Time frame: 4 weeks
It was used to measure range of motion of low back. An instrument for measuring angles is an inclinometer. A sensor is housed in the housing of an inclinometer. The sensor measures the housing's tilt and is sensitive to gravity. After that, the angle is shown on a dial or digital display.
Active Knee Extension Test
Time frame: 4 Week
The most effective way to exclude the hamstring muscle's extensibility range, with the hip fixed at a 90-degree angle and precise instrument placement, is to perform the active knee extension test. This technique provides accurate measures of hamstring length and extensibility when used in a supine 90/90 position. Both a normal goniometer and an electrogoniometer were used to measure the amount of extension. Whether hamstring tightness contributes to mechanical low back pain can be inferred from this result.
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 27 Dec 2024.
- 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.
Ali Raza, MS-OMPT 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 Dry Needling and Soft Tissue Mobilization in people with Hamstring Tightness and Chronic Low-back Pain, 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 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 4 weeks). The study lists 4 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 27 Dec 2024.