PNF With and Without Electrical Stimulation in Patients With Chronic Lumbar Radiculopathy

November 26, 2024 updated by: Riphah International University

Effect of Proprioceptive Neuromuscular Facilitation With and Without Electrical Stimulation on Pain and Functional Disability in Patients With Chronic Lumbar Radiculopathy

Numerous researches have shown how PNF is been used to treat non specific low back pain, subacromial impingement, cervical radiculopathy and many others. In some studies different techniques like Mckenzie method, spinal mobilization and Mulligan traction other than PNF were being used to treat lumbar radiculopathy. According to researchers knowledge little literature available to see the effectiveness of PNF with electrical stimulation in patients with chronic lumbar radiculopathy. Therefore, the purpose of the current study is to examine the effects of PNF with electrical stimulation in patients with chronic lumbar radiculopathy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Sialkot, Punjab, Pakistan, 51310
        • Amin welfare and teaching hospital , Awan center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Diagnosed cases of lumbar radiculopathy

    • Either one or both legs affected by radiating pain
    • Signs of nerve root compression like paresthesia, numbness, tingling, sharp pain
    • Impaired deep tendon reflex(knee jerk, ankle jerk)
    • Both male and female
    • Radiological evidence of lumbar spondylosis with radiculopathy
    • Age group between 40 to 70 years
    • Positive SLR test between 45° to 70°
    • All subjects with symptoms for duration of more than 6 weeks
    • Increase leg pain by coughing and sneezing

Exclusion Criteria:

  • Serious spinal conditions e.g infection, tumor, osteoporosis
  • Uncontrolled hypertension
  • Severe cognitive impairment
  • Other neurological conditions and systemic illness like kidney and visceral diseases
  • Vertebral fracture and spondylolisthesis
  • Pregnant women
  • History of spinal surgery in previous 6 months
  • Clinical conditions such as oversensitive skin, patients with cardiac pacemakers where application of TENS is contraindicated

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PNF with electrical stimulation
participants in this arm receive PNF with electrical stimulation to reduce pain and functional disability in patients with chronic lumbar radiculopathy
Other: PNF with electrical stimulation

Group A receive PNF including combination of isotonic and rhythmic stabilization on trunk with electrical stimulation Participants perform three sets10 repetitions at maximal resistance The resting interval of 30 seconds and 60 seconds will be provided after the completion of 10 repetitions for each pattern and between sets respectively.

In total all PNF exercise will be held for 30 to 45 minutes. 'BURST' TENS (acupuncture-like TENS), characterized by discontinuous stimulation at low frequencies (1-4 Hz), with wave durations of 100-400 ms and high intensities, inducing weak muscle twitches for 10 minutes.
Experimental: PNF without electrical stimulation
participants in this arm receive PNF without electrical stimulation to reduce pain and functional disability in patients with chronic lumbar radiculopathy
Other: PNF without electrical stimulation

Group B receive PNF including combination of isotonic and rhythmic stabilization on trunk without electrical stimulation. Participants perform three sets of 10 repetitions at maximal resistance will be provided by the same physiotherapist.

The resting interval of 30 seconds and 60 seconds will be provided after the completion of 10 repetitions for each pattern and between sets respectively.

In total all PNF exercise will be held for 30 to 45 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pain numeric rating scale
Time Frame: 6th week
The pain numeric rating scale is a segmented numeric version of visual analog scale in which a respondent selects a whole number 0 to 10 that reflects the intensity of pain. The 11 point numeric scale ranges from 0 representing no pain and 10 representing extreme pain. Higher scores indicating greater pain intensity. e.g. as bad as you can imagine or worst pain. NPRS takes less than 1 minute to complete and easy to administer and score.
6th week
Modified Oswestry disability index
Time Frame: 6th week
MODI also known as the Oswestry Low Back Pain Disability Questionnaire, as a very crucial instrument to assess a patient's functional disability over the long term. MODI is a patient completed questionnaire included 10 sections of questions. This tool is effective for persistent severe disability. The MODI domains are the following: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, travelling and employment/home making. Each section has six statements that are scored from 0 means minimum degree of difficulties in that activity to 5 means maximum degree of difficulty.
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arnab Altaf, PP DPT, Riphah International University Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/24/0214 Azka Yaseen

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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