Mechanical Low Back PainNCT05475912
Effect of Talocrural Joint Thrust Manipulation on Mechanical Low Back Pain
A study testing Group A, excercises in people with Mechanical Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Among all disabling musculoskeletal condition, non specific low back pain is most prevalent and universal condition. Its prevalence has increased over years and affects almost all at some phase in their life. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Group A, excercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 10 Jun 2022
- 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants falling in this category would be recruited into the study.
- Willingness of participant.
- Age group between 21-45 years (both male and female).
- Localized, Low back pain- Sub acute(6-12 weeks) and chronic low back pain(12 weeks and above)
- Asymptomatic Ankle- Pronated foot, Flat foot, Healed ankle injuries.
- Test for inclusion of foot: Feiss line test (Medial Longitudinal Arch Angle), Stress Test for Ankle ligaments (Anterior Drawer Test, Talar Tilt Test, Eversion Stress Test).
Who cannot join
- Participant failing to fall in this category would be excluded of the study.
- Any recent injury of spine or lower limb.
- Any unhealed ankle injuries.
- Patients with neurological deficit such as paresthesia, numbness and weakness in lower limb.
- Spondylolysis or any defect or stress fracture in the pars interarticularis of the vertebral arch.
- Spondylolisthesis or any displacement of vertebra.
Show all 17Show fewer
- Spinal fracture or any trauma in spinal column.
- Spinal tumors (both primary and metastatic tumor).
- Spinal surgery such as lumbar decompression surgery, lumbar fusion surgery.
- Artificial disc replacement surgery.
- Pregnancy.
- Disc prolapsed such as protrusion, prolapse, extrusion and sequestration.
- Any spinal curvature defect.
- Receiving steroid injection within previous 3 months.
- History of systemic disorder and malignancy.
- Diagnosed diabetic patients.
- Diagnosed Osteoporotic patients
Trial locations and contacts
1 site in 1 country.
About this study
Among all disabling musculoskeletal condition, non specific low back pain is most prevalent and universal condition. Its prevalence has increased over years and affects almost all at some phase in their life. Though, there are many causes of low back pain such as, sedentary life style, depression, poor nutritionist diet and so on, yet faulty posture is also one of the noteworthy causes of low back pain which cannot be overlooked. Faulty posture can result from any out of order body component, such as atypical foot biomechanics. Since lower limb is connected in a closed chain, atypical foot biomechanics leads to disruption in the whole chain ascending up to the spine, stressing spine soft tissues, upsetting its normal anatomical position and causing low back pain.
Read the detailed description
The lower limb is made up of all the structures from feet to pelvic, forming a closed mechanical chain. In this chain if any one segment is out of its neutral position it affects the whole chain. Like, if a foot is out of its alignment can be flattened or highly pronated, it will results in ankle internal rotation i,e. during the early stance phase of gait When the foot pronates, the calcaneus everts while the talus adducts and the plantar flexes. This inferomedial translation of the talus, results in inward rotation of shin and knee. Knee internal rotation, then make femur to rotate medially (internally) and pelvic to tilt anteriorly. This increased tilting of pelvic increases the curvature of the lumbar spine. Excessive curve at lumbar spine places excessive strain on the muscles, tendons and ligaments of the lower back, causing them to inflame and resulting pain. This domino effect, explains how a misalignment in the foot end up negatively effecting the health of one's lower back and a source of non specific low back pain.Though the direct treatment of lumbar region is important for LBP,yet ankle strategy is needed in order to correct the spinal imbalance. This research proceeded with the thought of taking a whole approach i.e. treating the main cause, causing LBP rather than just applying specific approach i.e. giving only symptomatic treatment for pain alleviation. With this approch talocrural/ankle joint is being taken within physical therapy treatment sphere through manipulation technique along with conventional physical therapy protocol for LBP in the current study.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Group A, excercises
- 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.
Group A, excercisesOther
Also called Group B,manipulation
Each group will receive treatment three times per week for 3 weeks total 7 sessions.
| Study group | Role | What they receive |
|---|---|---|
| group A, Conventional Pysical Therapy treatment | Experimental | group A will be given, Electrotherapy Modalities treatment:Hot pack - 20 min,Transcutaneous Electrical Nerve Stimulator - 30 min and will perfome Active Exercises including;Knee to chest exercise,Hamstring stretch, Pelvic bridging,Pelvic tilt, Lumbar rotation stretch exercise.(1set with10 reps of each excercise) Home exercise plan \& precautions; Perform above mentioned active exercises, 3 sessions per day (1sets x 10 reps) will also be given to Group A. Receives: Other: Group A, excercises |
| Group B, Talocrural joint manipulation and Conventional Physical Therapy treatment | Experimental | group Bwill be given, Talocrural Joint Manipulation with Electrotherapy Modalities treatment:Hot pack - 20 min,Transcutaneous Electrical Nerve Stimulator - 30 min and will perfome Active Exercises including;Knee to chest exercise,Hamstring stretch, Pelvic bridging,Pelvic tilt, Lumbar rotation stretch exercise.(1set with10 reps of each excercise) Home exercise plan \& precautions; Perform above mentioned active exercises, 3 sessions per day (1sets x 10 reps) will also be given to Group B. Receives: Other: Group A, excercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Effects of Talo-crural joint Thrust Manipulation along with Conventional Physiotherapy Treatment will be observed on Mechanical Low Back Pain, through visual analogue scale.
Findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
assesment will be made on baseline, before intervention, on 4th session after intervention and on 7th session after intervention.
Measured: 7 Day
Secondary outcomes (1)
Modified oswestry disability index
Effects of Talo-crural joint Thrust Manipulation along with Conventional Physiotherapy Treatment will be observed on quality of life among mechanical low back pain patients, through modified oswestry disability index.
ODI is made up of 10 questions. Each question is scored from 0-5 (minimum to maximum)
Assesment will be made on baseline, before intervention, on 4th session after intervention and on 7th session after intervention.
Measured: 7 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Mar 2022
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waqar Ahmed Awan, PhD, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475912
- Sponsor's protocol ID
- REC/01075 Kashmala
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Talocrural Joint Thrust Manipulation on Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT05475912
- Acronym / sponsor ID
- REC/01075 Kashmala
- Conditions
- Mechanical Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 27 Jul 2022 (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.
Among all disabling musculoskeletal condition, non specific low back pain is most prevalent and universal condition. Its prevalence has increased over years and affects almost all at some phase in their life. Though, there are many causes of low back pain such as, sedentary life style, depression, poor nutritionist diet and so on, yet faulty posture is also one of the noteworthy causes of low back pain which cannot be overlooked. Faulty posture can result from any out of order body component, such as atypical foot biomechanics. Since lower limb is connected in a closed chain, atypical foot biomechanics leads to disruption in the whole chain ascending up to the spine, stressing spine soft tissues, upsetting its normal anatomical position and causing low back pain.
Detailed description
The lower limb is made up of all the structures from feet to pelvic, forming a closed mechanical chain. In this chain if any one segment is out of its neutral position it affects the whole chain. Like, if a foot is out of its alignment can be flattened or highly pronated, it will results in ankle internal rotation i,e. during the early stance phase of gait When the foot pronates, the calcaneus everts while the talus adducts and the plantar flexes. This inferomedial translation of the talus, results in inward rotation of shin and knee. Knee internal rotation, then make femur to rotate medially (internally) and pelvic to tilt anteriorly. This increased tilting of pelvic increases the curvature of the lumbar spine. Excessive curve at lumbar spine places excessive strain on the muscles, tendons and ligaments of the lower back, causing them to inflame and resulting pain. This domino effect, explains how a misalignment in the foot end up negatively effecting the health of one's lower back and a source of non specific low back pain.Though the direct treatment of lumbar region is important for LBP,yet ankle strategy is needed in order to correct the spinal imbalance. This research proceeded with the thought of taking a whole approach i.e. treating the main cause, causing LBP rather than just applying specific approach i.e. giving only symptomatic treatment for pain alleviation. With this approch talocrural/ankle joint is being taken within physical therapy treatment sphere through manipulation technique along with conventional physical therapy protocol for LBP in the current study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A, Conventional Pysical Therapy treatment | Experimental | Other: Group A, excercisesgroup A will be given, Electrotherapy Modalities treatment:Hot pack - 20 min,Transcutaneous Electrical Nerve Stimulator - 30 min and will perfome Active Exercises including;Knee to chest exercise,Hamstring stretch, Pelvic bridging,Pelvic tilt, Lumbar rotation stretch exercise.(1set with10 reps of each excercise) Home exercise plan \& precautions; Perform above mentioned active exercises, 3 sessions per day (1sets x 10 reps) will also be given to Group A. |
| Group B, Talocrural joint manipulation and Conventional Physical Therapy treatment | Experimental | Other: Group A, excercisesgroup Bwill be given, Talocrural Joint Manipulation with Electrotherapy Modalities treatment:Hot pack - 20 min,Transcutaneous Electrical Nerve Stimulator - 30 min and will perfome Active Exercises including;Knee to chest exercise,Hamstring stretch, Pelvic bridging,Pelvic tilt, Lumbar rotation stretch exercise.(1set with10 reps of each excercise) Home exercise plan \& precautions; Perform above mentioned active exercises, 3 sessions per day (1sets x 10 reps) will also be given to Group B. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants falling in this category would be recruited into the study.
Key exclusion criteria (17 listed)
- Participant failing to fall in this category would be excluded of the study.
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 |
|---|---|---|
| Group A, excercisesAlso: Group B,manipulationEach group will receive treatment three times per week for 3 weeks total 7 sessions. | Other | Group B, Talocrural joint manipulation and Conventional Physical Therapy treatment, group A, Conventional Pysical Therapy treatment |
Primary outcome
Visual analogue scale
Time frame: 7 Day
Effects of Talo-crural joint Thrust Manipulation along with Conventional Physiotherapy Treatment will be observed on Mechanical Low Back Pain, through visual analogue scale. Findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. assesment will be made on baseline, before intervention, on 4th session after intervention and on 7th session after intervention.
1 secondary outcome
Modified oswestry disability index
Time frame: 7 Day
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 27 Jul 2022.
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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.
Waqar Ahmed Awan, PhD principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A, excercises in people with Mechanical 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 17 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 27 Jul 2022. 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?
Visual analogue scale (time frame: 7 Day). 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 Jul 2022.