Back PainNCT04815915
Effects of Graston Technique in Patients With Non Specific Low Back Pain
A study testing Graston technique in people with Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Non-specific low back pain upsets individuals of all age gathering and is a most significant provider to illness load everywhere on the world. Overseeing rules prescribe emergency to locate the uncommon instances of low back pain that are brought about by actually genuine pathology, thus need demonstrative work-up or… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Graston technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Apr 2020to 21 Jan 2021
- 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
- • Both genders
- Age (20-40 years)
- Patients with non-specific backache
- Trigger points and tender points at low back region
Who cannot join
- • Patients with chronic diseases
- Degenerative changes in spine
- Open wounds around the area to be treated
- High blood pressure
- Diabetic neuropathy
- Cancer (depending on the type and location)
- Taking anti-coagulants
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Non-specific low back pain upsets individuals of all age gathering and is a most significant provider to illness load everywhere on the world. Overseeing rules prescribe emergency to locate the uncommon instances of low back pain that are brought about by actually genuine pathology, thus need demonstrative work-up or proficient arrangement, or both. Since non-specific low back pain doesn't have a known pathoanatomical cause and treatment accentuations on diminishing in agony and its meanings.
To determine the impacts of Graston technique in patients with non-specific low back pain.
This examination was Quasi Experimental study and on the basis of inclusion standards, 20 patients were involved. PNRS and ODI used to collect the data. Graston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA. The data was analyzed using SPSS 21.
- Conditions
- Back Pain
- Being tested
- Graston technique
- Keywords
- Low Back Pain,Pain Numeric Rating Scale,Owestry Disability Index
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graston techniqueOther
Graston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Graston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA. Receives: Other: Graston technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
PNRS
Pain Numeric Rating Scale (PNRS) scores in subjects with moderate/severe pain at baseline. *P < 0.0001 vs. baseline. Includes only subjects with baseline PNRS score of 4 to 10. Scale ranges from 0 to 10. Data are shown as mean ± 95% confidence interval. n = 329 for all visits, all with a baseline PNRS score of 4 to 10.
Measured: 2 months
OSWESTRY DISABILITY INDEX
Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start5 Apr 2020
- Primary completion30 Dec 2020
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Shabbir, Riphah International University
- Investigators
- Iqra ZakaUllah, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815915
- Sponsor's protocol ID
- PT-MARYAM SHABBIR-1061
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
PubMed 27745712Koch C, Hansel F. Non-specific Low Back Pain and Postural Control During Quiet Standing-A Systematic Review. Front Psychol. 2019 Mar 22;10:586. doi: 10.3389/fpsyg.2019.00586. eCollection 2019.
PubMed 30967811Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
PubMed 21982256Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883.
PubMed 29321099Lakke SE, Soer R, Takken T, Reneman MF. Risk and prognostic factors for non-specific musculoskeletal pain: a synthesis of evidence from systematic reviews classified into ICF dimensions. Pain. 2009 Dec 15;147(1-3):153-64. doi: 10.1016/j.pain.2009.08.032. Epub 2009 Oct 2.
PubMed 19800735Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
PubMed 16034851Vanwye WR. Nonspecific low back pain: evaluation and treatment tips. J Fam Pract. 2010 Aug;59(8):445-8.
PubMed 20714454
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Graston Technique in Patients With Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT04815915
- Acronym / sponsor ID
- PT-MARYAM SHABBIR-1061
- Conditions
- Back Pain
- Keywords
- Low Back Pain,Pain Numeric Rating Scale,Owestry Disability Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Apr 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 25 Mar 2021 (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 upsets individuals of all age gathering and is a most significant provider to illness load everywhere on the world. Overseeing rules prescribe emergency to locate the uncommon instances of low back pain that are brought about by actually genuine pathology, thus need demonstrative work-up or proficient arrangement, or both. Since non-specific low back pain doesn't have a known pathoanatomical cause and treatment accentuations on diminishing in agony and its meanings.
To determine the impacts of Graston technique in patients with non-specific low back pain.
This examination was Quasi Experimental study and on the basis of inclusion standards, 20 patients were involved. PNRS and ODI used to collect the data. Graston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA. The data was analyzed using SPSS 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Graston techniqueGraston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Both genders
Key exclusion criteria (8 listed)
- • Patients with chronic 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 |
|---|---|---|
| Graston techniqueGraston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA. | Other | Study Group |
Primary outcome
PNRS
Time frame: 2 months
Pain Numeric Rating Scale (PNRS) scores in subjects with moderate/severe pain at baseline. *P < 0.0001 vs. baseline. Includes only subjects with baseline PNRS score of 4 to 10. Scale ranges from 0 to 10. Data are shown as mean ± 95% confidence interval. n = 329 for all visits, all with a baseline PNRS score of 4 to 10.
OSWESTRY DISABILITY INDEX
Time frame: 2 months
Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5
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 25 Mar 2021.
- Background: PubMed 27745712Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
- Background: PubMed 30967811Koch C, Hansel F. Non-specific Low Back Pain and Postural Control During Quiet Standing-A Systematic Review. Front Psychol. 2019 Mar 22;10:586. doi: 10.3389/fpsyg.2019.00586. eCollection 2019.
- Background: PubMed 21982256Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
- Background: PubMed 29321099Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883.
- Background: PubMed 19800735Lakke SE, Soer R, Takken T, Reneman MF. Risk and prognostic factors for non-specific musculoskeletal pain: a synthesis of evidence from systematic reviews classified into ICF dimensions. Pain. 2009 Dec 15;147(1-3):153-64. doi: 10.1016/j.pain.2009.08.032. Epub 2009 Oct 2.
- Background: PubMed 16034851Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
- Background: PubMed 20714454Vanwye WR. Nonspecific low back pain: evaluation and treatment tips. J Fam Pract. 2010 Aug;59(8):445-8.
- Individual participant dataSharing planned: No
Related trials for Back Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
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.
Iqra ZakaUllah, MS 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 in people with 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 4 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: finished, as of the sponsor's last update on 25 Mar 2021. 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?
PNRS (time frame: 2 months). The study lists 2 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 NCT04815915, which also lists 7 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 25 Mar 2021.