Low Back Pain, PosturalNCT05945056

Effectiveness of Frog Leg Technique in Management of Low Back Pain Due to Lumbar Lordosis

A study testing Frog Leg Exercise, Electrotherapy(Transcutaneous Electrical Nerve Stimulator) and Exercise Therapy in people with Low Back Pain, Postural, run by Health Education Research Foundation (HERF).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 20 to 45 years, women only
Conditions the study is for: Low Back Pain, Postural
What is being tested?: Frog Leg Exercise, Electrotherapy(Transcutaneous Electrical Nerve Stimulator) and Exercise Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: No sites listed yet
Study dates: 1 Sep 2015to 30 Nov 2016
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 20 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Females with age between 20 and 45 years
Patients with low back ache due to lumbar lordosis

Who cannot join

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.

About this study

Read the 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.

Conditions: Low Back Pain, Postural
Being tested: Frog Leg Exercise, Electrotherapy(Transcutaneous Electrical Nerve Stimulator), Exercise Therapy
Keywords: Low Back Pain, Frog Leg Technique, Exercise Therapy
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.

Frog Leg ExerciseOther
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.
Electrotherapy(Transcutaneous Electrical Nerve Stimulator)Other
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.
Exercise TherapyOther
Stretching of tight muscles(hip flexors and lower back extensors) Abdominal Curl-Ups and Bridging exercises.

Study groups in NCT05945056
Study group	Role	What they receive
Electrotherapy with Frog Leg Exercise Intervention	Experimental	Experimental group received Frog leg technique along with transcutaneous electrical nerve stimulation for 10 sessions of duration half hour each on regular basis. Receives: Other: Frog Leg Exercise; Other: Electrotherapy(Transcutaneous Electrical Nerve Stimulator)
Standard Exercise Therapy with Electrotherapy	Active comparator	Control group received standard exercise therapy treatment along with transcutaneous electrical nerve stimulation for 10 sessions of duration half hour each on regular basis. Receives: Other: Electrotherapy(Transcutaneous Electrical Nerve Stimulator); Other: Exercise Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pain
Visual Analogue Scale used to assess pain.
Measured: Data was Collected at Baseline, 5th Day & 10th Day.
Change in Disability Level
Oswestry Low Back Pain Disability Questionnaire used to assess level of disability.
Measured: Data was Collected at Baseline, 5th Day & 10th Day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201530 Nov 2016

First posted14 Jul 2023
Study start1 Sep 2015
Primary completion30 Nov 2016
Study completion30 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Back Pain, PosturalStudies 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
Masking: Single blind
Who is masked: Participant
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05945056
Sponsor's protocol ID: 1309-PPDPT-008/ANAM JAVED
Status last verified: Jul 2023
First submitted: 26 May 2023
Last updated: 14 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
Low Back Pain, Back Pain Lower Back Chronic
Not yet recruiting
Dual-Task Neuromuscular Warm-Up Exercises in Chronic Low Back Pain
Low Back Pain
Enrolling by invitation
Egoscue and Core Stabilization for Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
RecruitingObservational study
The Relationship Between Lost Extremity Percentage and Postural Control, Neck and Low Back Pain, Daily Living Activities, and Reaction Time in Individuals With Unilateral Upper Limb Amputation
Upper Limb Amputation, Postural Control
Not yet recruiting
Mirror Image Spine Correction Exercises Versus Conservative Physiotherapy for Lumbar Radiculopathy
Radiculopathy, Radiculopathy Lumbar

All Low Back Pain, Postural trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Frog Leg Technique in Management of Low Back Pain Due to Lumbar Lordosis
ClinicalTrials.gov ID: NCT05945056
Acronym / sponsor ID: 1309-PPDPT-008/ANAM JAVED
Conditions: Low Back Pain, Postural
Keywords: Low Back Pain, Frog Leg Technique, Exercise Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Health Education Research Foundation (HERF)University, hospital or other
Study start: 1 Sep 2015 (actual)
Primary completion: 30 Nov 2016 (actual)
Study completion: 30 Nov 2016 (actual)
First posted: 14 Jul 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Electrotherapy with Frog Leg Exercise Intervention	Experimental	Other: Frog Leg Exercise, Other: Electrotherapy(Transcutaneous Electrical Nerve Stimulator)Experimental group received Frog leg technique along with transcutaneous electrical nerve stimulation for 10 sessions of duration half hour each on regular basis.
Standard Exercise Therapy with Electrotherapy	Active comparator	Other: Electrotherapy(Transcutaneous Electrical Nerve Stimulator), Other: Exercise TherapyControl group received standard exercise therapy treatment along with transcutaneous electrical nerve stimulation for 10 sessions of duration half hour each on regular basis.

Who may qualify

Ages: 20 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Females with age between 20 and 45 years
Patients with low back ache due to lumbar lordosis

Key exclusion criteria (5 listed)

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.

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
Frog Leg ExerciseThe 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.	Other	Electrotherapy with Frog Leg Exercise Intervention
Electrotherapy(Transcutaneous Electrical Nerve Stimulator)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.	Other	Electrotherapy with Frog Leg Exercise Intervention, Standard Exercise Therapy with Electrotherapy
Exercise TherapyStretching of tight muscles(hip flexors and lower back extensors) Abdominal Curl-Ups and Bridging exercises.	Other	Standard Exercise Therapy with Electrotherapy

Primary outcome

Change in Pain
Time frame: Data was Collected at Baseline, 5th Day & 10th Day.
Visual Analogue Scale used to assess pain.
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.

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 14 Jul 2023.
Individual participant dataSharing planned: No

Related trials for Low Back Pain, Postural

RecruitingObservational study
The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
Low Back Pain, Back Pain Lower Back Chronic
Not yet recruiting
Dual-Task Neuromuscular Warm-Up Exercises in Chronic Low Back Pain
Low Back Pain
Enrolling by invitation
Egoscue and Core Stabilization for Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
RecruitingObservational study
The Relationship Between Lost Extremity Percentage and Postural Control, Neck and Low Back Pain, Daily Living Activities, and Reaction Time in Individuals With Unilateral Upper Limb Amputation
Upper Limb Amputation, Postural Control
Not yet recruiting
Mirror Image Spine Correction Exercises Versus Conservative Physiotherapy for Lumbar Radiculopathy
Radiculopathy, Radiculopathy Lumbar

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.

Anam Javed, Master principal investigator

Bashir Institute of Health Sciences

Questions about this trial

What is this clinical trial studying?

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 5 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 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Change in Pain (time frame: Data was Collected at Baseline, 5th Day & 10th Day.). 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?

On the ClinicalTrials.gov record for NCT05945056.

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 14 Jul 2023.