Low Back PainNCT06877767
Graston Versus Active Release Technique in Females With Non Specific Low Back Pain
A study testing Graston Technique and Active Release Technique in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Non-specific Low Back Pain defined by tension, soreness, and/or stiffness of the lower back with unknown origins of pain. Reduction in hamstrings flexibility has found to be one of the causes for development of low back pain. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Graston Technique and Active Release Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jan 2025to 15 Sep 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with Non Specific Low Back Pain
- Age group between 25 and 50 years
- History of NSLBP for at least 3 months
- Popliteal angle Numeric Rating Scale (NRS) score of 3-7/10
- The Oswestry Disability Index (ODI) score of 20-60
- Patients agree to sign written consent form.
Who cannot join
- Acute onset of pain and pain with radiation below knee.
- Any history of injury in the lower extremity in the past three months.
- Constant or persistent severe pain, inflammatory conditions (rheumatoid arthritis, ankylosing spondylitis)
- participants must not be taking any treatment of a musculoskeletal nature.
- Any previous surgery around the knee and hip
- hamstrings injury and strains
- Pregnant females
- Allergy to hot pack
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
Allama Iqbal Memorial Teaching Hospital
Sialkot, Punjab Province
Ghulam Fatima, PhD*, 03034073057, ghulam.fatima@riphah.edu.pk
Aneesa Javaid, MS*
About this study
Official title: Effects of Graston Versus Active Release Technique on Hamstring Flexibility, Pain and Disability in Females With Non Specific Low Back Pain
Non-specific Low Back Pain defined by tension, soreness, and/or stiffness of the lower back with unknown origins of pain. Reduction in hamstrings flexibility has found to be one of the causes for development of low back pain. Soft tissue manipulation can help loosen these muscles up and decrease a lot of the pain an individual may be having. Two specific kinds of soft tissue techniques will be utilized in this study are Graston Technique and Active Release Technique. So the aim of this project is to compare the effects of Graston Technique (GT) and Active Release Technique (ART) in the females with NSLBP. The study will be a randomized clinical trial and will be conducted in Allama Iqbal Memorial Teaching Hospital Sialkot. Non-probability convenience sampling technique will be used and participants will be recruited in groups after randomization. The subjects (n=40) will be divided into two groups. First group will include 20 women and graston technique will be applied. Group B will include 20 women and receive active release technique. Both the Groups will receive Hot Pack for 10 minutes, Passive stretching and Therapeutic Exercises for core stability; will be performed 2 times a week with 10 second hold of each exercise. Outcome measures will be taken using Numeric pain rating scale (NPRS) for pain, Universal Goniometer (GU) for Active knee extension test and popliteal angle measurement and Oswestry Disability Index for disability in the female patients with NSLBP. Outcome measures will be measured at baseline and after 4 weeks. Data analysis will be done by SPSS version 25.
Read the detailed description
Low back pain (LBP) is a condition experienced at least once by more than 80% of the human race the world over. More than 85% of cases of LBP in the USA are classified as nonspecific LBP defined by tension, soreness, and/or stiffness of the lower back with unknown origins of pain. Non-specific low back pain (NLBP) or "simple backache" is characterized as an LBP not due to any identifiable disease such as nerve root pain and severe spinal pathologies such as infection, tumor, osteoporosis, rheumatoid arthritis, fracture or inflammation. Back pain causes decreased lumbar extensibility, limited range of motion (LOM) and gait ability, and change of rhythm in the pelvis, limitations that can restrict social activities. One of the most widely studied outcomes in LBP patients is the reduction of hamstring extensibility. A shortening of the hamstring may result in LOM of the knee joint, restricting a person's ability to walk and run. In addition, it increases posterior pelvic tilting and reduces lumbar lordosis, contributing to a flat back that can result in low back. Methods for increasing the length of the shortened hamstring include stretching, eccentric resistance exercise, Graston instrument soft tissue mobilization, and self-myofascial release. Hamstring tightness is prevalent with the low back pain yet there is a need to establish a standardized treatment protocol for the condition. That's why this study will try to find out effective manner to release the pain and improve the flexibility of hamstring muscles.
The aim of this study is to determine the comparative effects of ART and Graston Technique specifically with each other on Hamstring flexibility, pain and disability in females with nonspecific low back pain. Therefore, this study will put into effect so that Graston Technique and ART can be compared against each other to see if one is more effective for restoration of full soft tissue function and relieving pain. This study will provide significant information that will aid in the creation of therapeutic interventions to improve pain, range of motion and functional limitations in females with non-specific low back pain. Graston Technique (GT) is a soft tissue mobilization treatment method using a tool that generates mechanical micro-traumatic damage to the treated area. In ART the goal is to remove the soft tissue adhesions by decreasing tissue tension. The muscle is taken from a shortened position to a lengthened position while a contact hand is holding tissue tension longitudinally along the soft tissue fibers.
- Conditions
- Low Back Pain
- Being tested
- Graston Technique, Active Release Technique
- Keywords
- disability evaluation, females, low back pain, pain assessment, Range of motion, Soft tissue
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graston TechniqueOther
Following the conventional treatment, this technique will be carried out through Graston tool called "GT-1" The special Graston Emollient or lubricant will be applied to the hamstrings of the subject then the tool used to find adhesions and break them up for 2.5 minutes per leg. First, the subject will lay prone and bent the knee joint to around 30° to 60°.The Graston instrument will be rubbed on each subject 30 times for 60 seconds from the gluteal line to the popliteal fossa. This treatment technique will be applied twice a week
Active Release TechniqueOther
Following the conventional treatment, subject received single session of ART on each side. There are 3 steps to perform ART. Step 1:Subject lies supine on the plinth and gentle tension was applied to the hamstring muscle along the entire length while stretching the leg in different positions to better work the muscle. Step 2: Gentle tension will be applied at the origin and insertion of the hamstring muscle. Step 3: The therapist will place tension on the bellies of hamstrings longitudinally at a specific tension \& ask the patient to extend his knee as per ART protocol.• This is done for 2.5 minutes on each leg. • This treatment technique will be applied twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Group A: graston technique | Experimental | Group A: baseline physical therapy treatment along with graston technique Receives: Other: Graston Technique |
| Group B: active release technique | Active comparator | Group B: baseline physical therapy treatment along with active release technique Receives: Other: Active Release Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The NPRS is a standardized self-report device consisting of a horizontal line used to estimate the subjective level of pain intensity. It is a 10 Points numerical scale, corresponding to the degree of pain. 1 being least level of pain and 10 being the highest level of pain.
Measured: 4 weeks
Oswestry Disability Index
Oswestry Disability Questionnaire will be used for measuring the level of disability in patients with low back pain. This questionnaire consists of 10 categories, each of which score on scale of 0-5, where 0 shows no disability and 5 shows the greatest disability. Each section caries 05 Questions describing minimum to maximum level of disability. The test is considered the 'gold standard' of low back functional outcome tools. It has 10 different sections. For each section the total possible score is 5. If all 10 sections are completed the score is calculated and interpreted in percentage measures.
Measured: 4 weeks
Universal Goniometer (UG)
Universal Goniometer (UG) is used for the measurement of popliteal angle and active knee extension test. To measure the popliteal angle, an active knee extension test will be applied. The the testing limb in 90º hip and knee flexion and the non testing limb in an extended with the subject supine on plinth, with the help of goniometer angle is measured between thigh and calf. For AKE test participants are positioned supine on a plinth. From this position, subjects are instructed to extend the knee until they felt a strong resistance, holding this final position for 2 to 3 seconds to allow the goniometric reading .
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start2 Jan 2025
- Primary completion2 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghulam Fatima, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877767
- Sponsor's protocol ID
- REC/RCR & AHS/24/0148
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allam NM, Eladl HM, Elruwaili LT, Elruwaili LF, Elbenya TJ, Elanzi EM, Elquobisi FF, Elgadoa HM, Elghaleb MA, Elsaeid MS, Elquarenes RA, Elrashed SM, Elmobarak SS, Elkholi SM, Eid MM, Alanazi AM, Nambi G, Abdelbasset WK. Correlation between hamstring muscle tightness and incidence of low back pain in female students at Jouf University, Saudi Arabia. Eur Rev Med Pharmacol Sci. 2022 Nov;26(21):7779-7787. doi: 10.26355/eurrev_202211_30127.
PubMed 36394725Sassonker K, Magnezi R, Moran D. Comparing right and left hamstring flexibility and its association to nonspecific lowr back pain among women of different age groups. J Bodyw Mov Ther. 2023 Oct;36:404-409. doi: 10.1016/j.jbmt.2023.07.014. Epub 2023 Sep 9.
PubMed 37949592Hori M, Hasegawa H, Takasaki H. Comparisons of hamstring flexibility between individuals with and without low back pain: systematic review with meta-analysis. Physiother Theory Pract. 2021 May;37(5):559-582. doi: 10.1080/09593985.2019.1639868. Epub 2019 Jul 18.
PubMed 31317831Nazary-Moghadam S, Yahya-Zadeh A, Zare MA, Ali Mohammadi M, Marouzi P, Zeinalzadeh A. Comparison of utilizing modified hold-relax, muscle energy technique, and instrument-assisted soft tissue mobilization on hamstring muscle length in healthy athletes: Randomized controlled trial. J Bodyw Mov Ther. 2023 Jul;35:151-157. doi: 10.1016/j.jbmt.2023.04.079. Epub 2023 Apr 21.
PubMed 37330762Moon JH, Jung JH, Won YS, Cho HY. Immediate effects of Graston Technique on hamstring muscle extensibility and pain intensity in patients with nonspecific low back pain. J Phys Ther Sci. 2017 Feb;29(2):224-227. doi: 10.1589/jpts.29.224. Epub 2017 Feb 24.
PubMed 28265144
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Graston Versus Active Release Technique on Hamstring Flexibility, Pain and Disability in Females With Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06877767
- Acronym / sponsor ID
- REC/RCR & AHS/24/0148
- Conditions
- Low Back Pain
- Keywords
- disability evaluation, females, low back pain, pain assessment, Range of motion, Soft tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 2 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 14 Mar 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.
Non-specific Low Back Pain defined by tension, soreness, and/or stiffness of the lower back with unknown origins of pain. Reduction in hamstrings flexibility has found to be one of the causes for development of low back pain. Soft tissue manipulation can help loosen these muscles up and decrease a lot of the pain an individual may be having. Two specific kinds of soft tissue techniques will be utilized in this study are Graston Technique and Active Release Technique. So the aim of this project is to compare the effects of Graston Technique (GT) and Active Release Technique (ART) in the females with NSLBP. The study will be a randomized clinical trial and will be conducted in Allama Iqbal Memorial Teaching Hospital Sialkot. Non-probability convenience sampling technique will be used and participants will be recruited in groups after randomization. The subjects (n=40) will be divided into two groups. First group will include 20 women and graston technique will be applied. Group B will include 20 women and receive active release technique. Both the Groups will receive Hot Pack for 10 minutes, Passive stretching and Therapeutic Exercises for core stability; will be performed 2 times a week with 10 second hold of each exercise. Outcome measures will be taken using Numeric pain rating scale (NPRS) for pain, Universal Goniometer (GU) for Active knee extension test and popliteal angle measurement and Oswestry Disability Index for disability in the female patients with NSLBP. Outcome measures will be measured at baseline and after 4 weeks. Data analysis will be done by SPSS version 25.
Detailed description
Low back pain (LBP) is a condition experienced at least once by more than 80% of the human race the world over. More than 85% of cases of LBP in the USA are classified as nonspecific LBP defined by tension, soreness, and/or stiffness of the lower back with unknown origins of pain. Non-specific low back pain (NLBP) or "simple backache" is characterized as an LBP not due to any identifiable disease such as nerve root pain and severe spinal pathologies such as infection, tumor, osteoporosis, rheumatoid arthritis, fracture or inflammation. Back pain causes decreased lumbar extensibility, limited range of motion (LOM) and gait ability, and change of rhythm in the pelvis, limitations that can restrict social activities. One of the most widely studied outcomes in LBP patients is the reduction of hamstring extensibility. A shortening of the hamstring may result in LOM of the knee joint, restricting a person's ability to walk and run. In addition, it increases posterior pelvic tilting and reduces lumbar lordosis, contributing to a flat back that can result in low back. Methods for increasing the length of the shortened hamstring include stretching, eccentric resistance exercise, Graston instrument soft tissue mobilization, and self-myofascial release. Hamstring tightness is prevalent with the low back pain yet there is a need to establish a standardized treatment protocol for the condition. That's why this study will try to find out effective manner to release the pain and improve the flexibility of hamstring muscles.
The aim of this study is to determine the comparative effects of ART and Graston Technique specifically with each other on Hamstring flexibility, pain and disability in females with nonspecific low back pain. Therefore, this study will put into effect so that Graston Technique and ART can be compared against each other to see if one is more effective for restoration of full soft tissue function and relieving pain. This study will provide significant information that will aid in the creation of therapeutic interventions to improve pain, range of motion and functional limitations in females with non-specific low back pain. Graston Technique (GT) is a soft tissue mobilization treatment method using a tool that generates mechanical micro-traumatic damage to the treated area. In ART the goal is to remove the soft tissue adhesions by decreasing tissue tension. The muscle is taken from a shortened position to a lengthened position while a contact hand is holding tissue tension longitudinally along the soft tissue fibers.
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: graston technique | Experimental | Other: Graston TechniqueGroup A: baseline physical therapy treatment along with graston technique |
| Group B: active release technique | Active comparator | Other: Active Release TechniqueGroup B: baseline physical therapy treatment along with active release technique |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females with Non Specific Low Back Pain
- Age group between 25 and 50 years
- History of NSLBP for at least 3 months
- Popliteal angle Numeric Rating Scale (NRS) score of 3-7/10
- The Oswestry Disability Index (ODI) score of 20-60
Key exclusion criteria (8 listed)
- Acute onset of pain and pain with radiation below knee.
- Any history of injury in the lower extremity in the past three months.
- Constant or persistent severe pain, inflammatory conditions (rheumatoid arthritis, ankylosing spondylitis)
- participants must not be taking any treatment of a musculoskeletal nature.
- Any previous surgery around the knee and hip
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 |
|---|---|---|
| Graston TechniqueFollowing the conventional treatment, this technique will be carried out through Graston tool called "GT-1" The special Graston Emollient or lubricant will be applied to the hamstrings of the subject then the tool used to find adhesions and break them up for 2.5 minutes per leg. First, the subject will lay prone and bent the knee joint to around 30° to 60°.The Graston instrument will be rubbed on each subject 30 times for 60 seconds from the gluteal line to the popliteal fossa. This treatment technique will be applied twice a week | Other | Group A: graston technique |
| Active Release TechniqueFollowing the conventional treatment, subject received single session of ART on each side. There are 3 steps to perform ART. Step 1:Subject lies supine on the plinth and gentle tension was applied to the hamstring muscle along the entire length while stretching the leg in different positions to better work the muscle. Step 2: Gentle tension will be applied at the origin and insertion of the hamstring muscle. Step 3: The therapist will place tension on the bellies of hamstrings longitudinally at a specific tension \& ask the patient to extend his knee as per ART protocol.• This is done for 2.5 minutes on each leg. • This treatment technique will be applied twice a week. | Other | Group B: active release technique |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4 weeks
The NPRS is a standardized self-report device consisting of a horizontal line used to estimate the subjective level of pain intensity. It is a 10 Points numerical scale, corresponding to the degree of pain. 1 being least level of pain and 10 being the highest level of pain.
Oswestry Disability Index
Time frame: 4 weeks
Oswestry Disability Questionnaire will be used for measuring the level of disability in patients with low back pain. This questionnaire consists of 10 categories, each of which score on scale of 0-5, where 0 shows no disability and 5 shows the greatest disability. Each section caries 05 Questions describing minimum to maximum level of disability. The test is considered the 'gold standard' of low back functional outcome tools. It has 10 different sections. For each section the total possible score is 5. If all 10 sections are completed the score is calculated and interpreted in percentage measures.
Universal Goniometer (UG)
Time frame: 4 weeks
Universal Goniometer (UG) is used for the measurement of popliteal angle and active knee extension test. To measure the popliteal angle, an active knee extension test will be applied. The the testing limb in 90º hip and knee flexion and the non testing limb in an extended with the subject supine on plinth, with the help of goniometer angle is measured between thigh and calf. For AKE test participants are positioned supine on a plinth. From this position, subjects are instructed to extend the knee until they felt a strong resistance, holding this final position for 2 to 3 seconds to allow the goniometric reading .
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 24 Mar 2025.
- Background: PubMed 36394725Allam NM, Eladl HM, Elruwaili LT, Elruwaili LF, Elbenya TJ, Elanzi EM, Elquobisi FF, Elgadoa HM, Elghaleb MA, Elsaeid MS, Elquarenes RA, Elrashed SM, Elmobarak SS, Elkholi SM, Eid MM, Alanazi AM, Nambi G, Abdelbasset WK. Correlation between hamstring muscle tightness and incidence of low back pain in female students at Jouf University, Saudi Arabia. Eur Rev Med Pharmacol Sci. 2022 Nov;26(21):7779-7787. doi: 10.26355/eurrev_202211_30127.
- Background: PubMed 37949592Sassonker K, Magnezi R, Moran D. Comparing right and left hamstring flexibility and its association to nonspecific lowr back pain among women of different age groups. J Bodyw Mov Ther. 2023 Oct;36:404-409. doi: 10.1016/j.jbmt.2023.07.014. Epub 2023 Sep 9.
- Background: PubMed 31317831Hori M, Hasegawa H, Takasaki H. Comparisons of hamstring flexibility between individuals with and without low back pain: systematic review with meta-analysis. Physiother Theory Pract. 2021 May;37(5):559-582. doi: 10.1080/09593985.2019.1639868. Epub 2019 Jul 18.
- Background: PubMed 37330762Nazary-Moghadam S, Yahya-Zadeh A, Zare MA, Ali Mohammadi M, Marouzi P, Zeinalzadeh A. Comparison of utilizing modified hold-relax, muscle energy technique, and instrument-assisted soft tissue mobilization on hamstring muscle length in healthy athletes: Randomized controlled trial. J Bodyw Mov Ther. 2023 Jul;35:151-157. doi: 10.1016/j.jbmt.2023.04.079. Epub 2023 Apr 21.
- Background: PubMed 28265144Moon JH, Jung JH, Won YS, Cho HY. Immediate effects of Graston Technique on hamstring muscle extensibility and pain intensity in patients with nonspecific low back pain. J Phys Ther Sci. 2017 Feb;29(2):224-227. doi: 10.1589/jpts.29.224. Epub 2017 Feb 24.
- 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.
Ghulam Fatima, 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 Graston Technique and Active Release Technique in people with 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 6 inclusion and 8 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 24 Mar 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?
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 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 NCT06877767, which also lists 5 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 24 Mar 2025.