Non Specific Low Back PainNCT06756776
Dry Needling vs. Stretching for Non-Specific Low Back Pain
A study testing Hot pack, Sustained Natural Apophyseal Glides (SNAG) and Passive Hamstring (HM) stretching in people with Non Specific Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Chronic low back pain (CLBP) is one of the common health issues and a leading cause of reduced mobility. It is characterized by pain during functional activities and is often associated with hamstring tightness. CLBP affects individuals across all age groups. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Non Specific Low Back Pain
- What is being tested?
- Hot pack, Sustained Natural Apophyseal Glides (SNAG) and Passive Hamstring (HM) stretching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2024to 30 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- minimum 3 months chronicity of low back pain
- with tight hamstrings and positive passive knee extension test (12)
Who cannot join
- Chronic systemic bony and soft tissue diseases
- Recent history of trauma
- Degenerative joint diseases
- Psychiatrist diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dry Needling Versus Stretching of Hamstrings Muscles With Lumber Sustained Natural Apophyseal Glides on Pain, Range of Motion, Muscle Length and Disability in Patients With Non-specific Low Back Pain
Chronic low back pain (CLBP) is one of the common health issues and a leading cause of reduced mobility. It is characterized by pain during functional activities and is often associated with hamstring tightness. CLBP affects individuals across all age groups. Various methods are used to address low back pain, including manual therapy. Manual therapy techniques include Maitland mobilizations, Kaltenborn mobilizations, Mulligan techniques, stretching, and others.
Several stretching techniques have been proposed, including static stretching, dynamic stretching, ballistic stretching, and proprioceptive neuromuscular facilitation (PNF). Among these, static and dynamic stretching are the most commonly used methods. Static stretching is considered one of the safest and easiest techniques, which can be performed passively or actively. Literature supports that stretching improves muscle flexibility, provides relaxation, reduces pain, and increases the range of motion (ROM).
Read more
Dry needling is another physical intervention technique that has been utilized for patients with musculoskeletal disorders. Current literature supports the use of dry needling for trigger points in hamstring muscles, which is a contributing factor to low back pain.
The objective of this study is to compare the effects of dry needling and stretching combined with sustained natural apophyseal glides (SNAGs) on pain, ROM, muscle length, and disability in patients with non-specific low back pain.
A randomized clinical trial will be conducted at Hijaz Hospital using convenience sampling to recruit participants. Patients will be allocated into two groups (Group A and Group B) through simple random sampling using sealed opaque envelopes. After conventional treatment, Group A will receive SNAGs and stretching, while Group B will receive SNAGs and dry needling.
Outcome measures will include the goniometer for ROM, the Modified Oswestry Disability Index (MODI) for disability, the Numeric Pain Rating Scale (NPRS) for pain, and the Finger-to-Floor Distance Test for hamstring flexibility. These measures will be assessed at baseline, at the 2nd week, and after 4 weeks. Data will be analyzed using SPSS software (version 21).
The normality of the data will be assessed using the Shapiro-Wilk test. Based on the results, parametric or non-parametric tests will be used for within-group and between-group comparisons. SNAGs and dry needling will be evaluated for their effectiveness in treating non-specific low back pain.
- Conditions
- Non Specific Low Back Pain
- Being tested
- Hot pack, Sustained Natural Apophyseal Glides (SNAG), Passive Hamstring (HM) stretching, Dry needling, Transcutaneous Electrical Nerve Stimulation
- Keywords
- non-specific low back pain, dry needling, SNAGs, ROM, disability, muscle length
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot packDevice
The Hot Pack is a therapeutic intervention device designed to deliver localized heat to targeted areas of the body for a duration of 15 minutes. It provides deep, soothing heat that helps to relax muscles, increase blood circulation, and reduce pain and stiffness. The device is typically used to treat conditions such as muscle tension, joint pain, and chronic discomfort. By applying consistent heat, the Hot Pack promotes improved tissue flexibility and alleviates muscle spasms. It is user-friendly, ensuring safe and effective use when applied to affected areas, with adjustable heat settings to accommodate individual needs.
Sustained Natural Apophyseal Glides (SNAG)Other
The Mulligan Sustained Natural Apophyseal Glides (SNAG) technique for the lumbar spine will be applied to participants in both groups. Participants will assume a stride standing position. The therapist will stand behind the participant as described by Mulligan, supporting the patient during the application of the technique and ensuring the required movement can be performed easily. The therapist will apply the mobilizing force parallel to the facet joint plane (in the cephalic direction) over the spinous processes of the respective symptomatic spinal levels in a sustained manner while the patient performs trunk flexion. The flexion position will be maintained for a few seconds, after which the participant will return to the starting position, with the therapist continuing to maintain the mobilizing force. Three sets of six repetitions will be performed on each symptomatic lumbar spinal level.
Passive Hamstring (HM) stretchingOther
Passive Hamstring (HM) stretching will be performed by a physical therapist experienced in the treatment of chronic low back pain (CLBP) and trained in the study protocol. The procedure will follow manual therapy stretching standards [22]. First, the physical therapist will explain the procedure to the participant and reassure them that the stretching can be stopped if it becomes too difficult to tolerate. With the participant lying supine, the stretched limb will be placed in maximal, pain-free hip flexion with the knee flexed. The physical therapist will then slowly and gradually extend the knee to the maximal pain-free position. In this position, participants should feel an intense stretching sensation in the back of the thigh. If this position causes pain in the lower back, the hip flexion will be reduced to the maximal, pain-free range of motion (ROM). A stopwatch will be used to ensure that the final position is held for 1 minute for each limb.
Dry needlingOther
Subjects will be positioned prone on a treatment table with their feet over the edge of the table. Dry needling (DN) will be applied to the hamstring muscles at three locations, each for 1 minute, using a fast in-out, cone-shaped technique.
Subjects will receive DN three times a week. To standardize the approach and optimize the application of DN, the points will be located approximately close to the motor points of the hamstring muscles.
Two of the locations are in the long and short heads of the biceps femoris, at points located at 30% and 60% of a straight line from the ischial tuberosity to the fibular head. For the semitendinosus and semitendinosus muscles, the DN location will be selected at 60% of a straight line from the ischial tuberosity to the medial femoral epicondyle.
Disposable sterilized stainless steel needles (0.3×60 mm; DongBang AcuPrime Ltd, Korea) will be used.
Transcutaneous Electrical Nerve StimulationDevice
The TENS (Transcutaneous Electrical Nerve Stimulation) unit is a therapeutic device designed to alleviate pain through the use of electrical impulses. It works by delivering low-voltage electrical currents via electrodes placed on the skin, targeting the affected area. These electrical pulses help to block pain signals sent to the brain and stimulate the production of endorphins, the body's natural pain relievers. The TENS unit is commonly used for managing both acute and chronic pain conditions, including muscle pain, joint pain, and nerve-related discomfort. The device is adjustable, allowing users to customize the intensity, duration, and frequency of the electrical stimulation to meet their individual needs. It is non-invasive, easy to use, and can be applied at home or in clinical settings for effective pain management.
| Study group | Role | What they receive |
|---|---|---|
| Group A: SNAGs on the lumbar spine and stretching | Experimental | Sustained Natural Apophyseal Glides (SNAGs) on the lumbar spine and stretching of the hamstring muscles will be administered to Group A. Receives: Device: Hot pack; Other: Sustained Natural Apophyseal Glides (SNAG); Other: Passive Hamstring (HM) stretching; Device: Transcutaneous Electrical Nerve Stimulation |
| SNAGs on the lumbar spine and dry needling | Active comparator | Sustained Natural Apophyseal Glides (SNAGs) on the lumbar spine and dry needling on the hamstring muscles will be administered to Group B. Receives: Device: Hot pack; Other: Sustained Natural Apophyseal Glides (SNAG); Other: Dry needling; Device: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
The patient's level of pain will be assessed using the Numeric Pain Rating Scale (NPRS), which ranges from 0 to 10. A score of 0 indicates "no pain," while a score of 10 represents the "worst pain imaginable." (19)
Measured: baseline, 2 weeks, and 4 weeks
Secondary outcomes (3)
Fingertip to Floor distance test
The finger-to-floor distance test can be used to assess spine stiffness and evaluate the effects of exercise on spine stiffness in individuals with spine disorders, such as ankylosing spondylitis and back pain. The reliability of the fingertip-to-floor test in patients with low back pain (LBP), assessed using the Intraclass Correlation Coefficient (ICC) and the Bland-Altman method, is excellent. After a functional restoration program, which includes daily exercises for flexibility, the test demonstrated good sensitivity to change, with an effect size of 0.87 and a Standardized Response Mean (SRM) of 0.97. The interobserver reliability of the fingertip-to-floor test is also high, with an ICC of 0.97 (unpublished data).
Measured: baseline, 2 weeks, and 4 weeks
Passive knee extension test
A study shows that the goniometer is reliable for measuring knee and elbow joint angles, with reliability values ranging from r = 0.67 to 0.70 (16). The purpose of the Passive Knee Extension Test (also known as the 90-90 Straight Leg Raise [SLR] hamstring test) is to assess the joint range of motion and the quality of its movement, particularly the 'end feel' of the joint. This test is commonly used to measure hamstring muscle tightness. A test-retest reliability study for this assessment shows a reliability range of 0.87 to 0.94, indicating high intra-rater reliability (21).
Measured: baseline, 2 weeks, and 4 weeks
Modified Oswestry Disability Index (ODI) (Urdu version)
The Modified Oswestry Disability Index (ODI) (Urdu version) will be used to assess the patient's functional disability due to chronic low back pain at baseline (0 weeks) and after 4 weeks. The modified ODI has a reliability score of 0.90.
Measured: baseline, 2 weeks, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start15 Jul 2024
- Primary completion30 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Specific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danish Hassan, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756776
- Sponsor's protocol ID
- Misbah Sohail
- Status last verified
- Jun 2025
- First submitted
- 20 Dec 2024
- Last updated
- 15 Jun 2025
- 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling Versus Stretching of Hamstrings Muscles With Lumber Sustained Natural Apophyseal Glides on Pain, Range of Motion, Muscle Length and Disability in Patients With Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06756776
- Acronym / sponsor ID
- Misbah Sohail
- Conditions
- Non Specific Low Back Pain
- Keywords
- non-specific low back pain, dry needling, SNAGs, ROM, disability, muscle length
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 3 Jan 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.
Chronic low back pain (CLBP) is one of the common health issues and a leading cause of reduced mobility. It is characterized by pain during functional activities and is often associated with hamstring tightness. CLBP affects individuals across all age groups. Various methods are used to address low back pain, including manual therapy. Manual therapy techniques include Maitland mobilizations, Kaltenborn mobilizations, Mulligan techniques, stretching, and others.
Several stretching techniques have been proposed, including static stretching, dynamic stretching, ballistic stretching, and proprioceptive neuromuscular facilitation (PNF). Among these, static and dynamic stretching are the most commonly used methods. Static stretching is considered one of the safest and easiest techniques, which can be performed passively or actively. Literature supports that stretching improves muscle flexibility, provides relaxation, reduces pain, and increases the range of motion (ROM).
Dry needling is another physical intervention technique that has been utilized for patients with musculoskeletal disorders. Current literature supports the use of dry needling for trigger points in hamstring muscles, which is a contributing factor to low back pain.
The objective of this study is to compare the effects of dry needling and stretching combined with sustained natural apophyseal glides (SNAGs) on pain, ROM, muscle length, and disability in patients with non-specific low back pain.
A randomized clinical trial will be conducted at Hijaz Hospital using convenience sampling to recruit participants. Patients will be allocated into two groups (Group A and Group B) through simple random sampling using sealed opaque envelopes. After conventional treatment, Group A will receive SNAGs and stretching, while Group B will receive SNAGs and dry needling.
Outcome measures will include the goniometer for ROM, the Modified Oswestry Disability Index (MODI) for disability, the Numeric Pain Rating Scale (NPRS) for pain, and the Finger-to-Floor Distance Test for hamstring flexibility. These measures will be assessed at baseline, at the 2nd week, and after 4 weeks. Data will be analyzed using SPSS software (version 21).
The normality of the data will be assessed using the Shapiro-Wilk test. Based on the results, parametric or non-parametric tests will be used for within-group and between-group comparisons. SNAGs and dry needling will be evaluated for their effectiveness in treating non-specific low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: SNAGs on the lumbar spine and stretching | Experimental | Device: Hot pack, Other: Sustained Natural Apophyseal Glides (SNAG), Other: Passive Hamstring (HM) stretching, Device: Transcutaneous Electrical Nerve StimulationSustained Natural Apophyseal Glides (SNAGs) on the lumbar spine and stretching of the hamstring muscles will be administered to Group A. |
| SNAGs on the lumbar spine and dry needling | Active comparator | Device: Hot pack, Other: Sustained Natural Apophyseal Glides (SNAG), Other: Dry needling, Device: Transcutaneous Electrical Nerve StimulationSustained Natural Apophyseal Glides (SNAGs) on the lumbar spine and dry needling on the hamstring muscles will be administered to Group B. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- minimum 3 months chronicity of low back pain
- with tight hamstrings and positive passive knee extension test (12)
Key exclusion criteria (4 listed)
- Chronic systemic bony and soft tissue diseases
- Recent history of trauma
- Degenerative joint diseases
- Psychiatrist diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot packThe Hot Pack is a therapeutic intervention device designed to deliver localized heat to targeted areas of the body for a duration of 15 minutes. It provides deep, soothing heat that helps to relax muscles, increase blood circulation, and reduce pain and stiffness. The device is typically used to treat conditions such as muscle tension, joint pain, and chronic discomfort. By applying consistent heat, the Hot Pack promotes improved tissue flexibility and alleviates muscle spasms. It is user-friendly, ensuring safe and effective use when applied to affected areas, with adjustable heat settings to accommodate individual needs. | Device | Group A: SNAGs on the lumbar spine and stretching, SNAGs on the lumbar spine and dry needling |
| Sustained Natural Apophyseal Glides (SNAG)The Mulligan Sustained Natural Apophyseal Glides (SNAG) technique for the lumbar spine will be applied to participants in both groups. Participants will assume a stride standing position. The therapist will stand behind the participant as described by Mulligan, supporting the patient during the application of the technique and ensuring the required movement can be performed easily. The therapist will apply the mobilizing force parallel to the facet joint plane (in the cephalic direction) over the spinous processes of the respective symptomatic spinal levels in a sustained manner while the patient performs trunk flexion. The flexion position will be maintained for a few seconds, after which the participant will return to the starting position, with the therapist continuing to maintain the mobilizing force. Three sets of six repetitions will be performed on each symptomatic lumbar spinal level. | Other | Group A: SNAGs on the lumbar spine and stretching, SNAGs on the lumbar spine and dry needling |
| Passive Hamstring (HM) stretchingPassive Hamstring (HM) stretching will be performed by a physical therapist experienced in the treatment of chronic low back pain (CLBP) and trained in the study protocol. The procedure will follow manual therapy stretching standards [22]. First, the physical therapist will explain the procedure to the participant and reassure them that the stretching can be stopped if it becomes too difficult to tolerate. With the participant lying supine, the stretched limb will be placed in maximal, pain-free hip flexion with the knee flexed. The physical therapist will then slowly and gradually extend the knee to the maximal pain-free position. In this position, participants should feel an intense stretching sensation in the back of the thigh. If this position causes pain in the lower back, the hip flexion will be reduced to the maximal, pain-free range of motion (ROM). A stopwatch will be used to ensure that the final position is held for 1 minute for each limb. | Other | Group A: SNAGs on the lumbar spine and stretching |
| Dry needlingSubjects will be positioned prone on a treatment table with their feet over the edge of the table. Dry needling (DN) will be applied to the hamstring muscles at three locations, each for 1 minute, using a fast in-out, cone-shaped technique. Subjects will receive DN three times a week. To standardize the approach and optimize the application of DN, the points will be located approximately close to the motor points of the hamstring muscles. Two of the locations are in the long and short heads of the biceps femoris, at points located at 30% and 60% of a straight line from the ischial tuberosity to the fibular head. For the semitendinosus and semitendinosus muscles, the DN location will be selected at 60% of a straight line from the ischial tuberosity to the medial femoral epicondyle. Disposable sterilized stainless steel needles (0.3×60 mm; DongBang AcuPrime Ltd, Korea) will be used. | Other | SNAGs on the lumbar spine and dry needling |
| Transcutaneous Electrical Nerve StimulationThe TENS (Transcutaneous Electrical Nerve Stimulation) unit is a therapeutic device designed to alleviate pain through the use of electrical impulses. It works by delivering low-voltage electrical currents via electrodes placed on the skin, targeting the affected area. These electrical pulses help to block pain signals sent to the brain and stimulate the production of endorphins, the body's natural pain relievers. The TENS unit is commonly used for managing both acute and chronic pain conditions, including muscle pain, joint pain, and nerve-related discomfort. The device is adjustable, allowing users to customize the intensity, duration, and frequency of the electrical stimulation to meet their individual needs. It is non-invasive, easy to use, and can be applied at home or in clinical settings for effective pain management. | Device | Group A: SNAGs on the lumbar spine and stretching, SNAGs on the lumbar spine and dry needling |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: baseline, 2 weeks, and 4 weeks
The patient's level of pain will be assessed using the Numeric Pain Rating Scale (NPRS), which ranges from 0 to 10. A score of 0 indicates "no pain," while a score of 10 represents the "worst pain imaginable." (19)
3 secondary outcomes
Fingertip to Floor distance test
Time frame: baseline, 2 weeks, and 4 weeks
Passive knee extension test
Time frame: baseline, 2 weeks, and 4 weeks
Modified Oswestry Disability Index (ODI) (Urdu version)
Time frame: baseline, 2 weeks, and 4 weeks
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 15 Jun 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.
Danish Hassan, PhD* 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 Hot pack, Sustained Natural Apophyseal Glides (SNAG) and Passive Hamstring (HM) stretching in people with Non Specific 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 2 inclusion and 4 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 15 Jun 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?
Numeric Pain Rating Scale (NPRS) (time frame: baseline, 2 weeks, and 4 weeks). 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 15 Jun 2025.