Lower Back PainNCT05649774
Effects of Taping & Exercise Therapy on Lower Back Musculoskeletal Conditions in Pakistani Patients
A study testing Therapy, Taping technique and Therapy with taping in people with Lower Back Pain and Musculoskeletal Diseases or Conditions, run by University of Karachi at 1 site in Pakistan.
Trial summary
Lower back pain has been one of the most frequently occurring musculoskeletal disorder among the females. This act as a global burden and is highly prevalent in our society. This pain can result in life long disability, loss of function and mobility among individuals. Read more about this study
- Who is it for?
- Ages 28 to 38 years, women only
- Conditions the study is for
- Lower Back Pain, Musculoskeletal Diseases or Conditions
- What is being tested?
- Therapy, Taping technique and Therapy with taping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Dec 2022to 25 Jan 2023
- 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 28 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females who were willing to participate.
- Participants with nonspecific lower back pain will only be included and screened through the screening questionnaire.
Who cannot join
- Post-menopausal women
- Females with any diagnosed co-morbidity.
- Back pain progressive to any neurological deficit
- Sustained or increased back pain with loss of appetite and unexplained weight loss accompanied with fever, nausea and chills
- With any known spinal or lower back pathology
- Tumor of the spine
Show all 12Show fewer
- Any underlying diseases of spinal cord (i.e, ankylosing spondylosis, spondolisthesis)
- With any steroid therapy for lower back pain in the past three months
- Any inflammatory rheumatic disease
- Sensitive skin or any skin allergy or dermatological condition
- Any rehabilitative services taken for the lower back pain in the past two months
- Rejection to manual conatct
Trial locations and contacts
1 site in 1 country.
About this study
Lower back pain has been one of the most frequently occurring musculoskeletal disorder among the females. This act as a global burden and is highly prevalent in our society. This pain can result in life long disability, loss of function and mobility among individuals. The female of the society suffers from lower back pain the most because of the under lying causes, prolong standing and stooping as well as because of hormonal changes in their bodies
Read the detailed description
After studying the prevalence of the lower back pain among the females of Pakistan, the investogator find the need to assess the type of their pain and find out the best way to ease their pains. The motive was to develop a treatment protocol whose effects last longer and is inexpensive for the management of lower back pain.
Moreover, the investigator decided to study that which treatment protocol is better when compared to another and what is the role of sham treatment when given to the patients.
- Being tested
- Therapy, Taping technique, Therapy with taping, SHAM
- Keywords
- Lower back pain, Non specific lower back pain
- Medical subject headings
- Low Back Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TherapyProcedure or surgery
Also called Myofascial Release
Only Myofascial Release will be provided
Taping techniqueProcedure or surgery
Also called Taping
Only Kinesiotaping will be provided
Therapy with tapingProcedure or surgery
Also called Therapy followed by taping
Myofascial release will be provided followed by Kinesiotaping
SHAMProcedure or surgery
Placebo Treatment will be given
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Release (MFR) | Active comparator | The therapist will place its hands on the T12-L1 levels as well as on the sacrum. A cross handed hold will be performed along the fascia. Then for the gluteus Medius and maximus muscle, the therapist will stand facing the participant's leg and closed to the superior border of participant's pelvis. The therapist will place the palm of the hand on the anterior surface, allowing the fingers to rest on the outer fibers of the gluteal muscles stabilizing the pelvis of the participants. Allow the participant to flex its knee while applying adequate amount of stretch on the hip joint in an open pack position. Hold, wait for the release and stretch again. for tensor fascia Latae, The therapist will place several slightly adducted fingers of its one hand on the superior fibers proximal to the insertion on the anterior superior iliac crest and the thumb as well as the other fingers of the other hand on the distal muscle fibers. Hold, wait for the release and stretch again. Receives: Procedure: Therapy |
| Kinesio Taping (KT) | Active comparator | Lumbar star correction technique was applied. 4 tape I strips will be cut. The paper from the center will be torn. The targeted area will be stretched as tolerated at the lumbar region. The therapist will apply 25% to 35% tension to the strip within the therapeutic zone over the target tissue. End the strip with no tension and activate the adhesive. For the second strip change the posture in order to change the stretch on the tissue, apply the second strip with 25% to 35% tension in the center of the tape and end with no tension. Activate the adhesive. Now flex the trunk and rotate on one side. Apply the third tape strip with 25% to 35% tension in the center of the tape. Apply the fourth tape strip with flexion and rotation on the opposite side again with 25% to 35% tension on the strip.
The tape will be changed 3 times per week. Receives: Procedure: Taping technique |
| Myofascial Release with Taping (MFKT) | Experimental | Same Protocol of MFR followed by KT Receives: Procedure: Therapy with taping |
| Placebo Treatment | Sham comparator | The control group received a sham myofascial release for 40 minutes per treatment session, three times a week for three weeks. The sham myofascial release was applied by gently placing the hands over the same areas treated in the MFR group,without sliding, just enough to maintain contact for the desired time. Receives: Procedure: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Back Pain
Numeric Pain Rating Scale
Measured: Change from baseline to week 3
Disability of lower back
Oswestry Disability Index
Measured: Change from baseline to week 3
Secondary outcomes (4)
Range of Motion
Flexion, Extension and Lateral Bending (L and R)
Measured: Change from baseline to week 3
Pain Pressure Threshold
Algometer was used to check the pain pressure threshold of Thoraco lumbar fascia, Gluteus Medius, Gluteus Maximus and Tensor Fascia Latae
Measured: Change from baseline to week 3
Tissue Hardness
Algometer was used to check the tissue hardness of Thoraco lumbar fascia, Gluteus Medius, Gluteus Maximus and Tensor Fascia Latae
Measured: Change from baseline to week 3
Quality of Life of patients with Lower back pain
36-Item Short Form Health Survey (SF-36)
Measured: Change from baseline to week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start14 Dec 2022
- Primary completion20 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower 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
- The study was a parallel group, four arm superiority trial with 1:1 allocation ratio and balanced randomization
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiran Arshad, University of Karachi
- Investigators
- Kiran Arshad, M.Phil, Principal investigator, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649774
- Sponsor's protocol ID
- KArshad
- Status last verified
- Jan 2023
- First submitted
- 19 Nov 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be collected in the form of distribution of questionnaire to the participants. Confidentiality of the participants will be maintained. Consent will be taken form participants before collection of data.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Taping & Exercise Therapy on Lower Back Musculoskeletal Conditions in Pakistani Patients
- ClinicalTrials.gov ID
- NCT05649774
- Acronym / sponsor ID
- KArshad
- Keywords
- Lower back pain, Non specific lower back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 14 Dec 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.
Lower back pain has been one of the most frequently occurring musculoskeletal disorder among the females. This act as a global burden and is highly prevalent in our society. This pain can result in life long disability, loss of function and mobility among individuals. The female of the society suffers from lower back pain the most because of the under lying causes, prolong standing and stooping as well as because of hormonal changes in their bodies
Detailed description
After studying the prevalence of the lower back pain among the females of Pakistan, the investogator find the need to assess the type of their pain and find out the best way to ease their pains. The motive was to develop a treatment protocol whose effects last longer and is inexpensive for the management of lower back pain.
Moreover, the investigator decided to study that which treatment protocol is better when compared to another and what is the role of sham treatment when given to the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The study was a parallel group, four arm superiority trial with 1:1 allocation ratio and balanced randomization
| Arm | Type | Receives |
|---|---|---|
| Myofascial Release (MFR) | Active comparator | Procedure: TherapyThe therapist will place its hands on the T12-L1 levels as well as on the sacrum. A cross handed hold will be performed along the fascia. Then for the gluteus Medius and maximus muscle, the therapist will stand facing the participant's leg and closed to the superior border of participant's pelvis. The therapist will place the palm of the hand on the anterior surface, allowing the fingers to rest on the outer fibers of the gluteal muscles stabilizing the pelvis of the participants. Allow the participant to flex its knee while applying adequate amount of stretch on the hip joint in an open pack position. Hold, wait for the release and stretch again. for tensor fascia Latae, The therapist will place several slightly adducted fingers of its one hand on the superior fibers proximal to the insertion on the anterior superior iliac crest and the thumb as well as the other fingers of the other hand on the distal muscle fibers. Hold, wait for the release and stretch again. |
| Kinesio Taping (KT) | Active comparator | Procedure: Taping techniqueLumbar star correction technique was applied. 4 tape I strips will be cut. The paper from the center will be torn. The targeted area will be stretched as tolerated at the lumbar region. The therapist will apply 25% to 35% tension to the strip within the therapeutic zone over the target tissue. End the strip with no tension and activate the adhesive. For the second strip change the posture in order to change the stretch on the tissue, apply the second strip with 25% to 35% tension in the center of the tape and end with no tension. Activate the adhesive. Now flex the trunk and rotate on one side. Apply the third tape strip with 25% to 35% tension in the center of the tape. Apply the fourth tape strip with flexion and rotation on the opposite side again with 25% to 35% tension on the strip. The tape will be changed 3 times per week. |
| Myofascial Release with Taping (MFKT) | Experimental | Procedure: Therapy with tapingSame Protocol of MFR followed by KT |
| Placebo Treatment | Sham comparator | Procedure: SHAMThe control group received a sham myofascial release for 40 minutes per treatment session, three times a week for three weeks. The sham myofascial release was applied by gently placing the hands over the same areas treated in the MFR group,without sliding, just enough to maintain contact for the desired time. |
Who may qualify
- Ages
- 28 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females who were willing to participate.
- Participants with nonspecific lower back pain will only be included and screened through the screening questionnaire.
Key exclusion criteria (12 listed)
- Post-menopausal women
- Females with any diagnosed co-morbidity.
- Back pain progressive to any neurological deficit
- Sustained or increased back pain with loss of appetite and unexplained weight loss accompanied with fever, nausea and chills
- With any known spinal or lower back pathology
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 |
|---|---|---|
| TherapyAlso: Myofascial ReleaseOnly Myofascial Release will be provided | Procedure or surgery | Myofascial Release (MFR) |
| Taping techniqueAlso: TapingOnly Kinesiotaping will be provided | Procedure or surgery | Kinesio Taping (KT) |
| Therapy with tapingAlso: Therapy followed by tapingMyofascial release will be provided followed by Kinesiotaping | Procedure or surgery | Myofascial Release with Taping (MFKT) |
| SHAMPlacebo Treatment will be given | Procedure or surgery | Placebo Treatment |
Primary outcome
Lower Back Pain
Time frame: Change from baseline to week 3
Numeric Pain Rating Scale
Disability of lower back
Time frame: Change from baseline to week 3
Oswestry Disability Index
4 secondary outcomes
Range of Motion
Time frame: Change from baseline to week 3
Pain Pressure Threshold
Time frame: Change from baseline to week 3
Tissue Hardness
Time frame: Change from baseline to week 3
Quality of Life of patients with Lower back pain
Time frame: Change from baseline to week 3
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 31 Jan 2023.
- Individual participant dataSharing planned: No. Data will be collected in the form of distribution of questionnaire to the participants. Confidentiality of the participants will be maintained. Consent will be taken form participants before collection of data.
Related trials for Lower Back 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
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Kiran Arshad, M.Phil principal investigator
University of Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy, Taping technique and Therapy with taping in people with Lower Back Pain and Musculoskeletal Diseases or Conditions, run by University of Karachi 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 2 inclusion and 12 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 31 Jan 2023. 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. Some participants in this study may receive a placebo. 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?
Lower Back Pain (time frame: Change from baseline to week 3). 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?
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 31 Jan 2023.