NCT04918238

Brief Summary

The purpose of the study to investigate the effect of muscle energy techniques on functional abilities of patients with chronic discogenic unilateral sciatica and to explain it from a physiological and functional point of view

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

June 2, 2021

Last Update Submit

June 2, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual analogue scale (VAS)

    Change from baseline Pain and at 2 months

    "through study completion, an average of 2 months"

  • Oswestry disability index scale

    Change from baseline disability and at 2 months

    "through study completion, an average of 2 months"

Study Arms (2)

conventional treatment Arm

ACTIVE COMPARATOR

All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.

Other: Conventional program

muscle energy technique arm

EXPERIMENTAL

Group A received muscle energy technique with lateral recumbent positioning along with Conventional Physiotherapy Program

Other: Conventional programOther: Muscle energy technique

Interventions

All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.

conventional treatment Armmuscle energy technique arm

The patient was in the lateral recumbent position on the side opposite to his, her side-bending dysfunction while the physiotherapist stood facing the subject. The physiotherapist monitored the lumbar area with one hand while with the other hand flexed the subject's knees and hips until the barrier was engaged at the vertebral segment being treated.

muscle energy technique arm

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • History of sciatica for more than 12 weeks or has at least 3 episodes of intermittent sciatica, each last for morethan 1 week eitheraccompanied with low back pain during the 3 months before thestudy. Medically and radiologically diagnosed as discogenic chronic sciatica with mild to moderate disability according to modified Rolland and Morris scale.
  • Both males and females, aged from 25 to 40 years old.
  • Be able to understand and follow the instructions during testing and treatment procedures

You may not qualify if:

  • Fracture of pelvis, spine or lower extremities.
  • Hospitalization for severe trauma.
  • Peripheral neuropathy of diabetes or any other autoimmune disease.
  • Systematic autoimmune disease such as rheumatoid arthritis, systematic lupus
  • People with red flags such as cancer or severe osteoporosis.
  • Symptoms provoked while doing active hip joint extension and abduction.
  • Previous surgery to the lumbar spine, abdomen, pelvis, or hip.
  • Any contraindication for exercise therapy (e.g. uncontrolled hypertension, previous myocardial infarction, cardiovascular disease, peripheral vascular disease, respiratory disorders).
  • Any pain originated because of SI pathology.
  • Menstruation during testing days.
  • Individuals incapable of understanding and answering the Questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic - Faculty of Physical Therapy - Horus University

Damietta, 34518, Egypt

Location

MeSH Terms

Conditions

SciaticaLow Back Pain

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 8, 2021

Study Start

February 1, 2021

Primary Completion

May 15, 2021

Study Completion

June 1, 2021

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations