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

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

Study Overview

• Status: Completed
• Conditions: Lower Back Pain; Musculoskeletal Diseases or Conditions
• Intervention / Treatment: Procedure: Therapy; Procedure: Taping technique; Procedure: Therapy with taping; Procedure: SHAM

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Al-Tibri Medical college and hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Myofascial Release (MFR); 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.	Procedure: Therapy; Only Myofascial Release will be provided; Other Names: Myofascial Release
Active Comparator: Kinesio Taping (KT); 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.	Procedure: Taping technique; Only Kinesiotaping will be provided; Other Names: Taping
Experimental: Myofascial Release with Taping (MFKT); Same Protocol of MFR followed by KT	Procedure: Therapy with taping; Myofascial release will be provided followed by Kinesiotaping; Other Names: Therapy followed by taping
Sham Comparator: Placebo Treatment; 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.	Procedure: SHAM; Placebo Treatment will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower Back Pain	Numeric Pain Rating Scale	Change from baseline to week 3
Disability of lower back	Oswestry Disability Index	Change from baseline to week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	Flexion, Extension and Lateral Bending (L and R)	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	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	Change from baseline to week 3
Quality of Life of patients with Lower back pain	36-Item Short Form Health Survey (SF-36)	Change from baseline to week 3

Collaborators and Investigators

• Sponsor: University of Karachi
• Investigators: Principal Investigator: Kiran Arshad, M.Phil, University of Karachi

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): October 20, 2022
• Study Completion (Actual): October 21, 2022

Study Registration Dates

• First Submitted: November 19, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Lower back pain; Non specific lower back pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Disease; Musculoskeletal Diseases
• Other Study ID Numbers: KArshad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No