Effect of Plantar Fascia Release on Patients With Chronic Non-specific Low Back Pain

NCT05892783 | Unknown

• 1 other identifier: PF release in CNSLB
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the current study is to determine the effect of myofascial release of plantar fascia on pain, back function, lumbar flexibility and pain pressure threshold for patients with CNSLBP.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (5)

• Assessment of Pain

  Therapist will assess pain intensity by using the Arabic version of Pain Numerical Rating Scale. It is 10 cm horizontal line with zero marked on one end (representing no pain) and 10 marked on the other end (representing worst imaginable pain).The scale will be explained to the patients first, then they will be asked to mark the best value that locates their pain level.

  Around 10 minutes

• Assessment of back function

  Back function will be assessed by using Oswestry disability index (ODI). The ODI is a functional scale that assesses the impact of LBP on daily activities. It is a self-administered, 10 item questionnaire in which: the first section rates the intensity of pain and the others describe its disability effect on typical daily activities. The patient will be asked to choose the answer that best describes his/her current functional status. If more than one statement is marked in each item, the highest score will be taken to give a total ODI score ranging from 0 to 50, which is multiplied by 2 to be expressed as a percentage score. The sum will be calculated and presented as a percentage, where 0% represents no disability and 100% represents the worst possible disability. Disability categorized within the scale as following: mild or no disability (0% -20%), moderate disability (21% -40%), severe disability (41% - 60%), incapacity (61% - 80%), restricted to bed (81% -100%).

  Around 15 to 30 mins

• Assessment of Lumbar flexibility

  Modified-Modified Schober's test. During lumbar flexion assessment, patients will be in the standing position, whereas the examiner will be in a kneeling position behind patients. The posterior superior iliac spines will be identified. A horizontal line will be made between both posterior superior iliac spines. One ink mark will be made at the level of the S2 vertebra, and another ink mark will be 15 cm above the first mark. The examiner will then fix a tape measure between those two marks. Next, the examiner will instruct the patient to bend forward. The new distance between the two marks will be measured. The change in the difference between the measurement marks in standing and in flexion will be used to specify the amount of lumbar flexion. Assessment of lumbar extension will be performed same way as for lumbar flexion with the exception that the examiner will instruct the patient to bend backward.

  15 to 30 mins

• Assessment of trigger points

  Trigger points will be assessed by using pressure algometer. Diagnosing myofascial trigger points will be applied as follows: 1. Tender spot in a taut band, 2. Patient pain recognition on tender spot palpation, 3. Predicted pain referral pattern (the pain distribution expected from a trigger point in that muscle), and 4. Local twitch response (a transient local contraction of skeletal muscle fibers in response to palpation or needling)

  Around 30 mins

• Hamstring flexibility

  The hamstring flexibility will be measured using the passive straight leg raise test and a standard universal goniometer. The axis will be on the knee joint, the stationary arm will be parallel to the axis of the femur, and the movable arm parallel to the leg. With the knee held straight, the participant's leg will be moved passively into hip flexion until tightness is felt. At that point, the physical therapist will read the goniometer in degrees of motion. Three trials will be performed on each leg, and the average will be used for recorded.

  15 to 30 mins

Study Arms (2)

experimental group

EXPERIMENTAL

This group will receive myofascial release on the PF of both legs, namely foam rolling, plantar fascia specific stretching and soft tissue mobilization.

Other: manual treatment

control group

NO INTERVENTION

This group will receive advice only.

Interventions

manual treatment OTHER

soft tissue mobilization applied by the therapist on the plantar fascia of both legs and self massage and stretching using foam roller and self stretching.

experimental group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders between the age of 20-45 years old.
• BMI less than 30 Kg/m2.
• Patients diagnosed as CNSLBP (pain \> 3 months).
• Minimum pain level 2 out of 10 in NPRS.
• Psychologically and mentally stable.
• At least on trigger point in the lumbar paraspinals.
• Minimal level of disability in ODI.
• Reduced hamstring flexibility.

You may not qualify if:

• Red flags (eg. Spinal fractures, tumors, infection).
• Cauda equina syndrome that requires urgent surgery.
• Pregnant patients.
• Previous lumbar surgery.
• Fibromyalgia.
• Disc lesions and spinal degenerative disease such as lumbar spondylosis.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: due to the nature of the study, neither the participants nor the investigator will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Essraa Mahmoud

Model Details: two parallel arms interventional studies

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 7, 2023
• Study Start: June 15, 2023
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-05