Low Back PainNCT04815941
Effects of Soft Ball Tissue Release Exercises on Low Back Pain Secondary to Tight Hip Muscles.
A study testing Soft ball tissue release exercises in people with Low Back Pain and Tight Hip Muscles, run by Riphah International University at 1 site in Pakistan.
Trial summary
It is also suggested that low back pain patients tend to have trigger point or tight muscles, i.e. Gluteus Maximus, Gluteus Medius, iliopsoas and Quardatus Lumborum, on at least one side.After approval from the university ethical committee, 23 (male, female) were enrolled in this study. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Low Back Pain, Tight Hip Muscles
- What is being tested?
- Soft ball tissue release exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2020to 30 Dec 2020
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 35-50 years Gender: Male and Female Low back pain for at least 12 weeks. Tight hip muscles (Priformis (FAIR test), TFL (Ober's test), Iliopsoas (Thomas test).
Who cannot join
- Any anatomical or neurophysiological causes of disease (X-ray and examination by a medical doctor) of spine.
- Abnormal past histories of the spine, i.e. spondylitis, fracture, etc. Neurologic diseases. Functional restrictions on the upper and lower limbs. Disc prolapse Lumber Spinal stenosis L4-5 Spondylolysthesis Any abnormality at Sacroilliac joint (Faber,Pattricks,thigh thurst, ASIS distraction, Sacral compression test)
Trial locations and contacts
1 site in 1 country.
About this study
It is also suggested that low back pain patients tend to have trigger point or tight muscles, i.e. Gluteus Maximus, Gluteus Medius, iliopsoas and Quardatus Lumborum, on at least one side.After approval from the university ethical committee, 23 (male, female) were enrolled in this study. All patients who presented nonspecific low back pain were included on the basis of inclusion and exclusion criteria. Demographic data of the patients were collected. Oswestry low back disability index was used to evaluate the disability level of low back. Piriformis muscle tightness was diagnosed among low back pain patients using FAIR (Flexion, abduction, internal rotation) and Freiberg's test. The FAIR test was performed on the patient in, side lying position, with the hip flexed at 60º and the knee flexed at 90º. With the hip being stabilized, a single examiner will internally rotate and adduct the hip by applying downward pressure onto the knee. Freiberg's test was performed on the patient in the supine position with the thigh extended. The leg and thigh are passively internally rotated by the examiner. If pain is registered, the test is positive. The effects of soft ball tissue release exercises on low back pain secondary to tight hip muscles
- Conditions
- Low Back Pain, Tight Hip Muscles
- Being tested
- Soft ball tissue release exercises
- Keywords
- Low Back Pain,Tight hip pain
- 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.
Soft ball tissue release exercisesOther
Exercise program were given to patients with low back pain secondary to hip muscle tightness using soft balls, i.e. tennis balls plus core stability exercises.
3 days a week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Soft ball tissue release exercises | Experimental | Not described Receives: Other: Soft ball tissue release exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 2 months
Neck disability Index
the overall score range is between 0 and 50, 0 being no to little pain and discomfort while 50 being the severest degree of pain and disability with complete activity limitation. The score is sometimes expressed in percentage as well.
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 start1 Apr 2020
- Primary completion30 Nov 2020
- Study completion30 Dec 2020
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Shabbir, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815941
- Sponsor's protocol ID
- REC/Lhr/1063
- Status last verified
- Aug 2021
- First submitted
- 24 Mar 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geiger F, Bengtsson J, Berendse F, Weisser WW, Emmerson M, Morales MB, et al. Persistent negative effects of pesticides on biodiversity and biological control potential on European farmland. Basic and Applied Ecology. 2010;11(2):97-105.
Casser HR, Seddigh S, Rauschmann M. Acute Lumbar Back Pain. Dtsch Arztebl Int. 2016 Apr 1;113(13):223-34. doi: 10.3238/arztebl.2016.0223.
PubMed 27120496Byrne DP, Mulhall KJ, Baker JF. Anatomy & biomechanics of the hip. The open sports medicine Journal. 2010;4(1).
Heneweer H, Vanhees L, Picavet HS. Physical activity and low back pain: a U-shaped relation? Pain. 2009 May;143(1-2):21-5. doi: 10.1016/j.pain.2008.12.033. Epub 2009 Feb 12.
PubMed 19217208Boyajian-O'Neill LA, McClain RL, Coleman MK, Thomas PP. Diagnosis and management of piriformis syndrome: an osteopathic approach. J Am Osteopath Assoc. 2008 Nov;108(11):657-64. doi: 10.7556/jaoa.2008.108.11.657.
PubMed 19011229Hopayian K, Song F, Riera R, Sambandan S. The clinical features of the piriformis syndrome: a systematic review. Eur Spine J. 2010 Dec;19(12):2095-109. doi: 10.1007/s00586-010-1504-9. Epub 2010 Jul 3.
PubMed 20596735Durrani Z, Winnie AP. Piriformis muscle syndrome: an underdiagnosed cause of sciatica. J Pain Symptom Manage. 1991 Aug;6(6):374-9. doi: 10.1016/0885-3924(91)90029-4.
PubMed 1880438
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Soft Ball Tissue Release Exercises on Low Back Pain Secondary to Tight Hip Muscles.
- ClinicalTrials.gov ID
- NCT04815941
- Acronym / sponsor ID
- REC/Lhr/1063
- Conditions
- Low Back Pain, Tight Hip Muscles
- Keywords
- Low Back Pain,Tight hip pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (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.
It is also suggested that low back pain patients tend to have trigger point or tight muscles, i.e. Gluteus Maximus, Gluteus Medius, iliopsoas and Quardatus Lumborum, on at least one side.After approval from the university ethical committee, 23 (male, female) were enrolled in this study. All patients who presented nonspecific low back pain were included on the basis of inclusion and exclusion criteria. Demographic data of the patients were collected. Oswestry low back disability index was used to evaluate the disability level of low back. Piriformis muscle tightness was diagnosed among low back pain patients using FAIR (Flexion, abduction, internal rotation) and Freiberg's test. The FAIR test was performed on the patient in, side lying position, with the hip flexed at 60º and the knee flexed at 90º. With the hip being stabilized, a single examiner will internally rotate and adduct the hip by applying downward pressure onto the knee. Freiberg's test was performed on the patient in the supine position with the thigh extended. The leg and thigh are passively internally rotated by the examiner. If pain is registered, the test is positive. The effects of soft ball tissue release exercises on low back pain secondary to tight hip muscles
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soft ball tissue release exercises | Experimental | Other: Soft ball tissue release exercises |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age: 35-50 years Gender: Male and Female Low back pain for at least 12 weeks. Tight hip muscles (Priformis (FAIR test), TFL (Ober's test), Iliopsoas (Thomas test).
Key exclusion criteria (2 listed)
- Any anatomical or neurophysiological causes of disease (X-ray and examination by a medical doctor) of spine.
- Abnormal past histories of the spine, i.e. spondylitis, fracture, etc. Neurologic diseases. Functional restrictions on the upper and lower limbs. Disc prolapse Lumber Spinal stenosis L4-5 Spondylolysthesis Any abnormality at Sacroilliac joint (Faber,Pattricks,thigh thurst, ASIS distraction, Sacral compression test)
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 |
|---|---|---|
| Soft ball tissue release exercisesExercise program were given to patients with low back pain secondary to hip muscle tightness using soft balls, i.e. tennis balls plus core stability exercises. 3 days a week for four weeks. | Other | Soft ball tissue release exercises |
Primary outcome
Numeric Pain Rating Scale
Time frame: 2 months
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Neck disability Index
Time frame: 2 months
the overall score range is between 0 and 50, 0 being no to little pain and discomfort while 50 being the severest degree of pain and disability with complete activity limitation. The score is sometimes expressed in percentage as well.
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 2 Sep 2021.
- BackgroundGeiger F, Bengtsson J, Berendse F, Weisser WW, Emmerson M, Morales MB, et al. Persistent negative effects of pesticides on biodiversity and biological control potential on European farmland. Basic and Applied Ecology. 2010;11(2):97-105.
- Background: PubMed 27120496Casser HR, Seddigh S, Rauschmann M. Acute Lumbar Back Pain. Dtsch Arztebl Int. 2016 Apr 1;113(13):223-34. doi: 10.3238/arztebl.2016.0223.
- BackgroundByrne DP, Mulhall KJ, Baker JF. Anatomy & biomechanics of the hip. The open sports medicine Journal. 2010;4(1).
- Background: PubMed 19217208Heneweer H, Vanhees L, Picavet HS. Physical activity and low back pain: a U-shaped relation? Pain. 2009 May;143(1-2):21-5. doi: 10.1016/j.pain.2008.12.033. Epub 2009 Feb 12.
- Background: PubMed 19011229Boyajian-O'Neill LA, McClain RL, Coleman MK, Thomas PP. Diagnosis and management of piriformis syndrome: an osteopathic approach. J Am Osteopath Assoc. 2008 Nov;108(11):657-64. doi: 10.7556/jaoa.2008.108.11.657.
- Background: PubMed 20596735Hopayian K, Song F, Riera R, Sambandan S. The clinical features of the piriformis syndrome: a systematic review. Eur Spine J. 2010 Dec;19(12):2095-109. doi: 10.1007/s00586-010-1504-9. Epub 2010 Jul 3.
- Background: PubMed 1880438Durrani Z, Winnie AP. Piriformis muscle syndrome: an underdiagnosed cause of sciatica. J Pain Symptom Manage. 1991 Aug;6(6):374-9. doi: 10.1016/0885-3924(91)90029-4.
- 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.
Maryam Shabbir, 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 Soft ball tissue release exercises in people with Low Back Pain and Tight Hip Muscles, 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 1 inclusion and 2 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 2 Sep 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?
Numeric Pain Rating Scale (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 NCT04815941, 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 2 Sep 2021.