Mechanical Low Back PainNCT04976582
Effect of the Dry Needling and Kinesio Taping in Management of Mechanical Low Back Pain
A study testing dry needle in people with Mechanical Low Back Pain, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
Low back pain (LBP) is an extremely common problem that most people experience at some point in their life. It is the leading cause of activity limitation and work absence throughout much of the world. In India, occurrence of LBP is also alarming. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- dry needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2021to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with age of 18 and above with non-specific chronic low back pain.
- Back pain of mechanical origin, apparently without a defined cause, for at least 12 weeks duration.
- Participants had not had any physical therapy treatment in the past six months and had never used Kinesio Taping and dry needling technique.
- Being asymptomatic, latent MTrPs in the muscle of lumbar region (pain during examination).
- The absence of skin allergies, Palpable taut bands (if muscle accessible).
- Recognition of usual local pain suffered by the patient pressing on the sensitive nodule on the taut bands (focally). (identification of active MTPs).
- Painful restriction of the full range of motion on passive stretching.
- The consent to physical examination, dry needling and kinesio taping application.
Who cannot join
- • Severe injury in the last 12 months.
- Previous spinal surgical intervention, neurological diseases or musculoskeletal dis-orders, pharmacological treatment at present.
- infection, open wound, rash, decreased blood circulation in the treatment area
- A pacemaker, or epilepsy, presence of skin diseases and pregnancy
- Serious spinal pathologies such as a tumor, an inflammatory disease or former fracture of L1-S1, symptoms of spinal stenosis, disc protrusion or nerve root compromise and degeneration established in more than two levels
- Subjects who had used or had prior knowledge of the Kinesio Taping and dry needling method.
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- generalized chronic pain, fibromyalgia, clinical sign of radiculopathy and peripheral nervous system diseases
- spondylolysis with or without spondylolisthesis, arthritis or osteoporosis and Congenital or acquired deformity
- ongoing psychiatric or somatic disease that excluded either one or both treatment alternatives
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Adeela Asad
Islamabad, Federal Capital, 44000
Adeela Asad, m.phil, 03165184758, adeelaasadfmdc@gmail.com
Asima Irshad, ph.d, 03345339123, asima0332@yahoo.com
About this study
Low back pain (LBP) is an extremely common problem that most people experience at some point in their life. It is the leading cause of activity limitation and work absence throughout much of the world. In India, occurrence of LBP is also alarming. Nearly 60% of the population has significant back pain at some time in their life. In Brazil, spinal pain (cervical, thoracic and lumbar) was considered the second most prevalent complaint, affecting approximately 13.5% of the population. It is estimated that globally 39% of the population will have at least one episode of back pain throughout their lives. In episodes of pain greater than 12 weeks (classified as chronic lower back pain), the prognosis is unfavorable and is highly associated with high treatment costs and work absenteeism.
Non-specific low back pain" [NSLBP] is defined as, low back pain that is not attributable to a recognizable or known specific pathology - bone disorder in the spine [fracture], radicular nerve compression, slipped intervertebral disk, stenosis in lumbar spine, inflammatory disorder of spine [ankylosing spondylitis], cauda equine syndrome, congenital back disorder, infection in the spine [discitis], tumour in lumbar area, osteoporosis, meningitis, Cancer, HIV, autoimmune disorder [RA].
Read the detailed description
HYPOTHESIS:
Null hypothesis: There is significant effects of dry needling with conventional physiotherapy treatment as compared to Kinesio Taping with conventional physiotherapy treatment.
Alternate hypothesis: There is no significant effects of dry needling with conventional physiotherapy treatment as compared to Kinesio Taping with conventional physiotherapy treatment.
OBJECTIVES:
The aim of this study is:
- To determine the effects of dry needling in management of mechanical low back pain.
- To determine the effects of kinesio taping in management of mechanical low back pain.
- To determine the quality of life in patient with mechanical low back pain.
- To determine the varying degree of disability measure in patient with mechanical low back pain.
MATERIAL AND METHODS
3.1. Study Design Study will be a randomized control trial (RCT).
3.2. Settings The study will be conducted in the Rawal General and Dental Hospital Islamabad and Al-Nafees hospital Islamabad.
3.3. Duration of Study The duration of study will be completed in 04 months after approval of synopsis.
3.4. Sample Size Thirty patients will be enrolled in the study. Patients will be divided into groups i.e; 15 patients in each group
3.5. Sampling Technique Non probability convenient sampling. 3.6. Assessment: A pre-intervention assessment will be performed to each participant before they will be randomly assigned to kinesio taping group or dry needling group with physical therapy intervention and outcome measures will be recorded before the intervention i.e; baseline assessment ,after 2 weeks of intervention and after four weeks of treatment. After treatment, patients will be performed post-intervention assessment.
3.7. INTERVENTION: Participants will be divided into two groups Group 1: control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
Group 2: experimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
3.8. Treatment plan: There will be a 4 weeks treatment plan consisting of 12 sessions. On each week 3 sessions will be conducted.
- Conditions
- Mechanical Low Back Pain
- Being tested
- dry needle
- Keywords
- kinesio-taping, dry needling, low back 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.
dry needleDevice
Also called Exercise including McKenzie exercises
modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | experimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered. Receives: Device: dry needle |
| control group | No intervention | control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of dry needling and kinesio taping in management of mechanical low back pain.
mechanical low back pain will be measured using Roland Morris low back questionnaire and Pain Numeric Rating scale calculated as mean score.
Measured: 6 months
Secondary outcomes (1)
Quality of life in patient with mechanical low back pain
Determine the quality of life in patient with mechanical low back pain by using WHO-QOL Questionnaire in term of domain score.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
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
- Model description
- Participants will be divided into two groups Group 1: control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered. Group 2: experimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Adeela Asad, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Adeela Asad, m.phil, Principal investigator, Rawal Institue of Health Sciences Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976582
- Sponsor's protocol ID
- not applicale
- Status last verified
- Jul 2021
- First submitted
- 11 Nov 2020
- Last updated
- 26 Jul 2021
- 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 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Dry Needling and Kinesio Taping in Management of Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT04976582
- Acronym / sponsor ID
- not applicale
- Conditions
- Mechanical Low Back Pain
- Keywords
- kinesio-taping, dry needling, low back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 26 Jul 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.
Low back pain (LBP) is an extremely common problem that most people experience at some point in their life. It is the leading cause of activity limitation and work absence throughout much of the world. In India, occurrence of LBP is also alarming. Nearly 60% of the population has significant back pain at some time in their life. In Brazil, spinal pain (cervical, thoracic and lumbar) was considered the second most prevalent complaint, affecting approximately 13.5% of the population. It is estimated that globally 39% of the population will have at least one episode of back pain throughout their lives. In episodes of pain greater than 12 weeks (classified as chronic lower back pain), the prognosis is unfavorable and is highly associated with high treatment costs and work absenteeism.
Non-specific low back pain" [NSLBP] is defined as, low back pain that is not attributable to a recognizable or known specific pathology - bone disorder in the spine [fracture], radicular nerve compression, slipped intervertebral disk, stenosis in lumbar spine, inflammatory disorder of spine [ankylosing spondylitis], cauda equine syndrome, congenital back disorder, infection in the spine [discitis], tumour in lumbar area, osteoporosis, meningitis, Cancer, HIV, autoimmune disorder [RA].
Detailed description
HYPOTHESIS:
Null hypothesis: There is significant effects of dry needling with conventional physiotherapy treatment as compared to Kinesio Taping with conventional physiotherapy treatment.
Alternate hypothesis: There is no significant effects of dry needling with conventional physiotherapy treatment as compared to Kinesio Taping with conventional physiotherapy treatment.
OBJECTIVES:
The aim of this study is:
- To determine the effects of dry needling in management of mechanical low back pain.
- To determine the effects of kinesio taping in management of mechanical low back pain.
- To determine the quality of life in patient with mechanical low back pain.
- To determine the varying degree of disability measure in patient with mechanical low back pain.
MATERIAL AND METHODS
3.1. Study Design Study will be a randomized control trial (RCT).
3.2. Settings The study will be conducted in the Rawal General and Dental Hospital Islamabad and Al-Nafees hospital Islamabad.
3.3. Duration of Study The duration of study will be completed in 04 months after approval of synopsis.
3.4. Sample Size Thirty patients will be enrolled in the study. Patients will be divided into groups i.e; 15 patients in each group
3.5. Sampling Technique Non probability convenient sampling. 3.6. Assessment: A pre-intervention assessment will be performed to each participant before they will be randomly assigned to kinesio taping group or dry needling group with physical therapy intervention and outcome measures will be recorded before the intervention i.e; baseline assessment ,after 2 weeks of intervention and after four weeks of treatment. After treatment, patients will be performed post-intervention assessment.
3.7. INTERVENTION: Participants will be divided into two groups Group 1: control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
Group 2: experimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
3.8. Treatment plan: There will be a 4 weeks treatment plan consisting of 12 sessions. On each week 3 sessions will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be divided into two groups Group 1: control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered. Group 2: experimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Device: dry needleexperimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered. |
| control group | No intervention | –control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with age of 18 and above with non-specific chronic low back pain.
- Back pain of mechanical origin, apparently without a defined cause, for at least 12 weeks duration.
- Participants had not had any physical therapy treatment in the past six months and had never used Kinesio Taping and dry needling technique.
- Being asymptomatic, latent MTrPs in the muscle of lumbar region (pain during examination).
- The absence of skin allergies, Palpable taut bands (if muscle accessible).
Key exclusion criteria (9 listed)
- • Severe injury in the last 12 months.
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 |
|---|---|---|
| dry needleAlso: Exercise including McKenzie exercisesmodalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered. | Device | interventional group |
Primary outcome
comparison of dry needling and kinesio taping in management of mechanical low back pain.
Time frame: 6 months
mechanical low back pain will be measured using Roland Morris low back questionnaire and Pain Numeric Rating scale calculated as mean score.
1 secondary outcome
Quality of life in patient with mechanical low back pain
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
Related trials for Mechanical Low Back Pain
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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
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Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
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Fusion or Not - a Study on Low Back Pain
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Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
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Adia Med of Winter Park LLC Lower Back Pain Research Study
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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.
Adeela Asad, m.phil principal investigator
Rawal Institue of Health Sciences 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 dry needle in people with Mechanical Low Back Pain, run by Shaheed Zulfiqar Ali Bhutto Medical 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adeela Asad, m.phil (03165184758, adeelaasadfmdc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of dry needling and kinesio taping in management of mechanical low back pain. (time frame: 6 months). 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 26 Jul 2021.