Effects of Pain Neuroscience Education With Conventional Physical Therapy in Patients With Chronic Low Back Pain

NCT ID: NCT05680506

Last Updated: 2023-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Low back pain is currently considered to be the most common cause of disability.When low back pain occurs sensitivity of body increases which decreases overall body activity.Physical inactivity negatively effects recovery from chronic low back pain.Patients with chronic low back pain experience psychological anxiety and depression which leads to fear of pain and movement.There are various treatment options for chronic low back pain.But most treatment options deal with biomedical aspect of disease.Pain neuroscience education deals with psychological aspect of disease.By combining both treatment options we will be able to evaluate the combined biopsychosocial aspect of treatment.This study will mainly focus on the education of patients regarding neuroscience be hind their chronic low back pain.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Low back pain is currently considered to be the most common cause of disability.This is the single greatest cause of years lived with disability.When low back pain occurs the sensitivity of body increases which decreases overall body activity.Physical inactivity negatively effects recovery from chronic low back pain.Patients with chronic low back pain experience psychological anxiety and depression which leads to fear of pain and movement. There are various treatmet options for chronic low back pain.But most treatment options deal with biomedical aspect of disease.Pain neuroscience education deals with psychological aspect of disease.By combining both treatment options we will be able to evaluate the combined biopsychosocial aspect of treatment.This study will mainly focus on education of patients regarding neuroscience behind their chronic low back pain.

A randomized control trial will be conducted in Tariq Memorial Neuro Clinic Islambad using non-probability purposive sampling.Participants will be briefed regarding the study objectives, procedure, risks and benefits of treament, voluntary participation and right to withdraw.Written informed consent will be taken from all the participants before conducting the research.Details of exercise program will be explained to them.Patients wiith chronic low back pain will be reffered by neuro-physician.Screening will be done by using Keel Start Back screening tool.Then the selected participants will be randomized into 2 groups(experimental group and control group)via sealed envelope method. Participants will complete Numeric Rating Pain Scale(NRPS) for pain, Roland Morris Disability Questionnaire for disability measurement and Tampa Scale for kinesiophobia.All of these measurements will be taken at baseline and then after 4 weeks of intervention.

The treatment protocol of both groups is as follows:

Group 1(Control group):hot pack, TENS for 15 mins, mobilization at L4-L5 segment, stretchings and stabilization exercises (5 reps/1set) Group 2(Experimental group):Pain neuroscience education for 15 mins, hot pack, TENS,mobilization at L4-L5 segment, stretchings and stabilization exercises.(5 reps/1 set)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low-back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized controlled trial which will consist of two groups. One will recieve conventional physcial therapy only and the second will recieve conventional physcial therapy with pain neuroscience education.Both groups will be recruited concurrently.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor will be a another person who will be unaware of the group the particpant belong to

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pain neuroscience education group

Pain neuroscience education 10- 15min Hot pack(10 min) TENS Kaltenborn Moilization technique at L4-L5 segment stretchings and stabilization exercises. (5 reps/1 set) Total duration:40 min/session

Group Type EXPERIMENTAL

Pain neuroscience education

Intervention Type PROCEDURE

Pain neuroscience education will be given in form videos,pictures, stories and metaphors for 2 times per week for 4 weeks.

Standard Therapy

Intervention Type PROCEDURE

Hot pack,TENS, Kaltenborn grade 1 and 2 mobilizations, stretchings and lumbar stabilization exercises

Standard therapy group

Hot pack(10 min) TENS Kaltenborn Mobilization technique at L4-L5 segment stretchings and stabilization exercises (5 reps /1 set) Total duration:30 min/session

Group Type ACTIVE_COMPARATOR

Standard Therapy

Intervention Type PROCEDURE

Hot pack,TENS, Kaltenborn grade 1 and 2 mobilizations, stretchings and lumbar stabilization exercises

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pain neuroscience education

Pain neuroscience education will be given in form videos,pictures, stories and metaphors for 2 times per week for 4 weeks.

Intervention Type PROCEDURE

Standard Therapy

Hot pack,TENS, Kaltenborn grade 1 and 2 mobilizations, stretchings and lumbar stabilization exercises

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Both male and female of age 40-65 years
* Patients with chronic primary low back pain (medium risk patients on Start Back Screening Tool)

Exclusion Criteria

* patients with motor and sensory dysfunction
* patients with neurological abnormalities and muscle paalysis
* patients with dizziness and uncontrolled hypertension
* patients who could not take the basic posture of lumbar stabilization exercises because of pain
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Foundation University Islamabad

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FUI/CTR/2022/21

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.