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Effects of Taping & Exercise Therapy on Lower Back Musculoskeletal Conditions in Pakistani Patients

Primary Purpose

Lower Back Pain, Musculoskeletal Diseases or Conditions

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Therapy
Taping technique
Therapy with taping
SHAM
Sponsored by
University of Karachi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain focused on measuring Lower back pain, Non specific lower back pain

Eligibility Criteria

28 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Females who were willing to participate. Participants with nonspecific lower back pain will only be included and screened through the screening questionnaire. Exclusion Criteria: 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 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

Sites / Locations

  • Al-Tibri Medical college and hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Sham Comparator

Arm Label

Myofascial Release (MFR)

Kinesio Taping (KT)

Myofascial Release with Taping (MFKT)

Placebo Treatment

Arm Description

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.

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.

Same Protocol of MFR followed by KT

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.

Outcomes

Primary Outcome Measures

Lower Back Pain
Numeric Pain Rating Scale
Disability of lower back
Oswestry Disability Index

Secondary Outcome Measures

Range of Motion
Flexion, Extension and Lateral Bending (L and R)
Pain Pressure Threshold
Algometer was used to check the pain pressure threshold of Thoraco lumbar fascia, Gluteus Medius, Gluteus Maximus and Tensor Fascia Latae
Tissue Hardness
Algometer was used to check the tissue hardness of Thoraco lumbar fascia, Gluteus Medius, Gluteus Maximus and Tensor Fascia Latae
Quality of Life of patients with Lower back pain
36-Item Short Form Health Survey (SF-36)

Full Information

First Posted
November 19, 2022
Last Updated
January 29, 2023
Sponsor
University of Karachi
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1. Study Identification

Unique Protocol Identification Number
NCT05649774
Brief Title
Effects of Taping & Exercise Therapy on Lower Back Musculoskeletal Conditions in Pakistani Patients
Official Title
Effects of Taping & Exercise Therapy on Lower Back Musculoskeletal Conditions in Pakistani Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Karachi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain, Musculoskeletal Diseases or Conditions
Keywords
Lower back pain, Non specific lower back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was a parallel group, four arm superiority trial with 1:1 allocation ratio and balanced randomization
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myofascial Release (MFR)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Kinesio Taping (KT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Myofascial Release with Taping (MFKT)
Arm Type
Experimental
Arm Description
Same Protocol of MFR followed by KT
Arm Title
Placebo Treatment
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Therapy
Other Intervention Name(s)
Myofascial Release
Intervention Description
Only Myofascial Release will be provided
Intervention Type
Procedure
Intervention Name(s)
Taping technique
Other Intervention Name(s)
Taping
Intervention Description
Only Kinesiotaping will be provided
Intervention Type
Procedure
Intervention Name(s)
Therapy with taping
Other Intervention Name(s)
Therapy followed by taping
Intervention Description
Myofascial release will be provided followed by Kinesiotaping
Intervention Type
Procedure
Intervention Name(s)
SHAM
Intervention Description
Placebo Treatment will be given
Primary Outcome Measure Information:
Title
Lower Back Pain
Description
Numeric Pain Rating Scale
Time Frame
Change from baseline to week 3
Title
Disability of lower back
Description
Oswestry Disability Index
Time Frame
Change from baseline to week 3
Secondary Outcome Measure Information:
Title
Range of Motion
Description
Flexion, Extension and Lateral Bending (L and R)
Time Frame
Change from baseline to week 3
Title
Pain Pressure Threshold
Description
Algometer was used to check the pain pressure threshold of Thoraco lumbar fascia, Gluteus Medius, Gluteus Maximus and Tensor Fascia Latae
Time Frame
Change from baseline to week 3
Title
Tissue Hardness
Description
Algometer was used to check the tissue hardness of Thoraco lumbar fascia, Gluteus Medius, Gluteus Maximus and Tensor Fascia Latae
Time Frame
Change from baseline to week 3
Title
Quality of Life of patients with Lower back pain
Description
36-Item Short Form Health Survey (SF-36)
Time Frame
Change from baseline to week 3

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only females will be included in the study because lower back pain is highly prevalent among them.
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females who were willing to participate. Participants with nonspecific lower back pain will only be included and screened through the screening questionnaire. Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiran Arshad, M.Phil
Organizational Affiliation
University of Karachi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Tibri Medical college and hospital
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

Effects of Taping & Exercise Therapy on Lower Back Musculoskeletal Conditions in Pakistani Patients

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