A Suggested Functional Exercises Program For Patients With Chronic Mechanical Low Back Pain

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 25 to 45 years
• All sexes
• No healthy volunteers
• Adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Chronic Mechanical Low Back Pain

Being tested

advices, exercises plus advices

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• advicesOther

  The following advice will be given to the patients :

  1. Walking as flexibly (normally) as possible
  2. Advise when lifting ;

  • avoid twisting and bending.
  • for heavy objects use thighs with a vertical back.
  • at other times, use the back and flex it.

  1. Heat application for 20 mins twice /day .
  2. Avoid sitting or standing for prolonged period and change position every 15 mins.
  3. Sitting: Sit with a back support
  4. Driving: Use a back support (lumbar roll) at the curve of your back.
  5. Sleeping and lying down: Select a firm mattress and box spring set that does not sag. If necessary, place a board under your mattress. You can also place the mattress on the floor temporarily if necessary.

• exercises plus advicesOther

  Also called a suggested functional exercise program plus advises.

  In addition to the same advice of group A, a suggested functional exercise will be performed for this group.

  1. Sidestepping against band resistance:
  2. The quadriped opposite arm leg aganist resistance .
  3. Squat row on a balance board with band resistance:
  4. Front raise single leg support with band resistance:
  5. The Advanced Prone Bridge:
  6. Side sliding on a fitter board (lateral lunge with band):

What is being measured

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

1. pain in lower back

   will be measured by The Numeric Pain Rating Scale (NPRS). it consists of The 11-point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable .patients are asked to indicate the point along the line that best reflect their pain intensity .

   Measured: change from max pain point in 1 month

2. functional disability

   will be measured by Arabic version of Oswestry Disability Index (ODI) is a self-reported questionnaire consisting of 10 questions related to back function . Each question is answered on a 6-item Likert scale and is scored from 0 (minimum degree of difficulty in that activity) to 5 (maximum degree of difficulty). These questions assess the activities of daily living in patients with LBP. The questions in the index include pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling.

   The validity of Arabic version of ODI is good intra-observer reliability was excellent . The correlations of the ODI with the VAS pain scale, the Roland-Morris Low Back Pain Disability and the Quebec Back Pain Disability.

   Measured: change in 1 month

3. core muscles stability

   The researcher will conduct a series of core stability tests before and after the core training program. Core stability tests has been reported to be highly reliable (ICC ≥ 0.98) and showed moderate to high correlation with one another (correation coefficient ranged from 0.4 to 0.8) , The following core tests will be used: trunk flexion test (McGill's test) , Trunk extension (Sorenson Test) , Side plank test and prone plank test .

   Measured: change in 1 month

4. lower limb function

   will measured by Functional assessment using one legged hops test The most commonly used functional tests are a series of one-legged hops described by Noyes et al. (1991). The sensitivity of the single (49%), triple (50%), crossover (58%), and timed (52%) hop tests were reported by Noyes et al. (1991). The specificity was 97% and 94% for the timed and single hops, respectively

   Measured: change in 1 month

Timeline

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

1. First posted16 May 2023
2. Study start1 Feb 2023
3. Primary completionFeb 2024 (estimated)
4. Study completionNov 2024 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Chronic Mechanical Low Back PainStudies 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.