NCT05945056

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

May 26, 2023

Last Update Submit

July 11, 2023

Conditions

Keywords

Low Back PainFrog Leg TechniqueExercise Therapy

Outcome Measures

Primary Outcomes (2)

  • Change in Pain

    Visual Analogue Scale used to assess pain.

    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.

    Data was Collected at Baseline, 5th Day & 10th Day.

Study Arms (2)

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.

Other: Frog Leg ExerciseOther: 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.

Other: Electrotherapy(Transcutaneous Electrical Nerve Stimulator)Other: Exercise Therapy

Interventions

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 with Frog Leg Exercise Intervention

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.

Electrotherapy with Frog Leg Exercise InterventionStandard Exercise Therapy with Electrotherapy

Stretching of tight muscles(hip flexors and lower back extensors) Abdominal Curl-Ups and Bridging exercises.

Standard Exercise Therapy with Electrotherapy

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales suffer more from lumbar lordosis,hence female participants were selected for study.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Anam Javed, Master

    Bashir Institute of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

May 26, 2023

First Posted

July 14, 2023

Study Start

September 1, 2015

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share