- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05945056
Effectiveness of Frog Leg Technique in Management of Low Back Pain Due to Lumbar Lordosis
July 11, 2023 updated by: Mamoona Tasleem Afzal, Health Education Research Foundation (HERF)
Condition in which lumbar region experiences stress or extra weight and is arched to point of muscle pain or spasms is called Lumbar hyperlordosis.The study findings compared the effectiveness of frog leg technique and standard exercise therapy in management of low back pain due to lumbar lordosis.
Study Overview
Status
Completed
Conditions
Detailed Description
In adult population, a major health problem is Low back pain.
Postural change is one of the risk factor.
Abnormal posture causes strain on ligaments and muscles, as a result indirectly affects the curvature of the lumbar spine.Condition in which lumbar region experiences stress or extra weight and is arched to point of muscle pain or spasms is called Lumbar hyperlordosis.The study findings compared the effectiveness of frog leg technique and standard exercise therapy in management of low back pain due to lumbar lordosis.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Females with age between 20 and 45 years
- Patients with low back ache due to lumbar lordosis
Exclusion Criteria:
- History of surgery
- Patients with discogenic backache.
- Backache in pregnancy.
- Patients with traumatic history.
- Patients with pain due to any reason other than lumbar lordosis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Electrotherapy with Frog Leg Exercise Intervention
Experimental group received Frog leg technique along with transcutaneous electrical nerve stimulation for 10 sessions of duration half hour each on regular basis.
|
The patient lies supine with legs flexed, knees apart and the soles of the feet put together on couch.
The physiotherapist stands at the side of the table, moves one arm between the legs to place the hand under the sacrum and cup it.
The fingers spread to accommodate the spinous process of the fifth lumbar vertebra.
The tips of the fingers contact and grasp the junction of the fifth lumbar vertebra and the base of the sacrum.
This hand will give traction in a caudal direction throughout the procedure to move the sacral base posteriorly and the apex interiorly.
patient is asked to take a deep breath and hold it, while at the same time they steadily slide the feet downward toward the end of the table.Then patient brings their legs back to the frog leg position, but as they do so the therapist maintains traction preventing the sacrum from moving cephalad.
Procedure is repeated for a total of 8 repetitions.
TENS or transcutaneous electrical nerve stimulator is a low voltage electric current to relieve pain.
A small battery-operated TENS device which has leads connected to sticky pads called electrodes was used in treatment.
Patient in lying position gets pads directly attached to skin of lumbar region.
Small electrical impulses delivered to the affected area of the patient's body when the machine is switched on, which patient feel as a tingling sensation.
|
|
Active Comparator: Standard Exercise Therapy with Electrotherapy
Control group received standard exercise therapy treatment along with transcutaneous electrical nerve stimulation for 10 sessions of duration half hour each on regular basis.
|
TENS or transcutaneous electrical nerve stimulator is a low voltage electric current to relieve pain.
A small battery-operated TENS device which has leads connected to sticky pads called electrodes was used in treatment.
Patient in lying position gets pads directly attached to skin of lumbar region.
Small electrical impulses delivered to the affected area of the patient's body when the machine is switched on, which patient feel as a tingling sensation.
Stretching of tight muscles(hip flexors and lower back extensors) Abdominal Curl-Ups and Bridging exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain
Time Frame: Data was Collected at Baseline, 5th Day & 10th Day.
|
Visual Analogue Scale used to assess pain.
|
Data was Collected at Baseline, 5th Day & 10th Day.
|
|
Change in Disability Level
Time Frame: Data was Collected at Baseline, 5th Day & 10th Day.
|
Oswestry Low Back Pain Disability Questionnaire used to assess level of disability.
|
Data was Collected at Baseline, 5th Day & 10th Day.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anam Javed, Master, Bashir Institute of Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Actual)
November 30, 2016
Study Completion (Actual)
November 30, 2016
Study Registration Dates
First Submitted
May 26, 2023
First Submitted That Met QC Criteria
July 11, 2023
First Posted (Actual)
July 14, 2023
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
July 11, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1309-PPDPT-008/ANAM JAVED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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