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Low Back PainNCT04619134

Non Pain Contingent Spine Rehabilitation Therapy in Chronic Low Back Pain

A study testing NCSR Program and conventional physical therapy in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of study is to determine effects of non pain contingent spine rehabilitation in chronic low back pain.A Randomized controlled trial will be conducted at Railway general hospital. Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Low Back Pain
What is being tested?
NCSR Program and conventional physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
1 Dec 2019to 20 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

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 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with non-specific chronic low back pain(>3months)

Who cannot join

  • Spinal surgery
  • Compression Fracture
  • Disc Herniation
  • Cauda equina
  • Pregnancy
  • Cancer
  • Progressive neurological disorder
  • Any Psychological disorder

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Pakistan Railway General Hospital

    Rawalpindi, Punjab Province, 46000

Other trials in Pakistan

About this study

Official title: Effects of Non Pain Contingent Spine Rehabilitation Therapy in Chronic Low Back Pain

The aim of study is to determine effects of non pain contingent spine rehabilitation in chronic low back pain.A Randomized controlled trial will be conducted at Railway general hospital.

Sample size will be 32.Participants will be divided in two groups, 16 participants in group A will receive Non pain contingent spine rehabilitation (NCSR) therapy and 16 Group B will receive conventional physical therapy. The study duration will be six months. Purposive non probability sampling technique will be applied.

Read the detailed description

Low back pain is defined as pain and discomfort below the costal margin and above the inferior gluteal folds. It has different characteristics such as aching, burning, stabbing, sharp or dull, well-defined, or vague. Low back pain may have intensity varying from mild to severe . Low back pain (LBP) causes more disability than any other medical condition worldwide Low Back Pain has a significant impact on functional capacity, as pain restricts occupational activities and is a major cause of absenteeism. Chronic low Back pain is defined as chronic when pain remains for more than three months it has different characteristics. Many authors define chronic pain as pain that lasts beyond the expected period of healing. Low back pain is classified and treated according to duration of symptoms, cause, absence or presence of radiculopathy and associated anatomical and radiographic changes. Symptoms persisting for less than 4 weeks is defined as acute low back pain and in sub-acute low back pain symptoms lasts for 4-12 weeks, chronic low back pain lasts for more than 12 weeks. Back pain can also be categorized into specific and nonspecific back pain, Specific back pain has a specific cause for example fracture and infection etc. and nonspecific is of unknown etiology. Non-specific pain is most common type of back pain. The prevalence of low back pain has been reported among many people especially when resulting from work related and occupational activities 75-84% of the general population suffer from low back pain and among them, it is estimated that 5-10% of the people experience LBP resulting in severe morbidity, increased health care costs, sick leaves and individual suffering. Men and women are equally reported to be affected by this condition. Core muscles maintain spinal stability, first group include deep core muscles also called local stabilizing muscles primarily include the transversus abdominis, lumbar multifidus, internal oblique muscle and quadratus lumborum. Second group include shallow core muscles, also known as global stabilizing muscles, including the rectus abdominis, internal and external oblique muscles, erector spinae, quadratus lumborum, and hip muscles. The causes of chronic low back pain are complex, several of which are unknown one major cause involves the weakening of the shallow trunk and abdominal muscle, another cause of chronic low back pain is the weakening of deep trunk muscles, such as the lumbar multifidus and transversus abdominis. Patients usually experience pain during lifting it leads to avoidance behavior and cause disability. Less intensive and cost effective non pain contingent rehabilitation therapy could target fear avoidance behavior toward lifting and in restoration of normal function.

In female patients with chronic low back pain, Primary outcome measures were recorded by visual analogue scale (VAS) and oswestry disability index (ODI) .Patterns of improvement suggested that the Non pain Contingent Spinal Rehabilitation approach is more effective than Conventional Physical Therapy in female patients with chronic low back pain. It is feasible to adapt progressive Isoinertial lifting evaluation for determining the lifting capacity, it is a valid and reliable method. Lumbar dynamic strengthening exercises are beneficial in the treatment of chronic nonspecific LBP for reduction of pain, improvement in functional ability, increase range of motion and improve core strength. Exercise intervention programs involving either muscular strength, flexibility or aerobic fitness is beneficial for nonspecific chronic low back pain. Effects of lumbar stabilization exercise on functional disability and lumbar lordosis angle in patients with chronic low back pain in 2015 Lumbar stabilization exercise and conservative program were performed 3 times a week for 6 weeks and he reported that lumbar stabilization exercise is more effective than conservative treatment for improving functional disability and lumbar lordosis angle, and significant decrease in Oswestry disability index score. Comparative effect of core muscles strength training with supine bridging over prone bridging in patients with nonspecific low back pain and concluded that prone bridging exercise is more effective in improvement of functional activities and reducing pain than supine bridging exercise program in nonspecific low back pain. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain" in which he reported that Core stabilization exercise is more effective than routine physical therapy exercise in terms of greater reduction in pain in patients with non-specific low back pain. In 2013 The purpose of the study was to determine the effect of core stabilization exercises in comparison with conventional exercises on pain, functional status in patients with non-specific LBP and they concluded Core stabilization exercises found to be more effective in reducing pain and improving functional status by decreasing disability of patients with non-specific low back pain in comparison with conventional exercises. Progressive Isoinertial Lift Evaluation (PILE) method was developed by Mayer et al.in PILE protocol describes it as lifting of weight in a box from floor to waist (lumbar test) or from floor to shoulder height (cervical test) at a rate of four lifts in a 20 second interval.

Conditions
Low Back Pain
Being tested
NCSR Program, conventional physical therapy
Keywords
Low Back Pain, Non Pain Contingent Spine Rehabilitation
Medical subject headings
Low Back Pain

What participants receive

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

  • NCSR ProgramOther

    flexibility exercise,strengthening exercise,dynamic strengthening exercise,endurance training,counselling session

  • conventional physical therapyOther

    hot pack,flexibility training,strengthening exercise.

Study groups in NCT04619134
Study groupRoleWhat they receive
NCSR ProgramExperimentalNon Pain Contingent Spinal Rehabilitation
Receives: Other: NCSR Program
Conventional Physical therapyActive comparatorConventional Physical Therapy
Receives: Other: conventional physical therapy

What is being measured

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

  1. Visual Analog Scale

    Visual analogue scale (VAS) is a simple and frequently used method for the assessment of variations in intensity of pain. The VAS consists of a 10cm horizontal line with the words "no pain" and "worst pain" at the line's end. VAS is a reliable and valid tool to reliable and valid tool to measure pain intensity measure pain intensity. Changes from the baseline will be measured and at 4th week and then at 6th week

    Measured: 6th week

  2. Functional Disability: Oswestry Disability Index

    The Oswestry Disability Index (ODI) is one of the most commonly used outcome measures for the evaluation and treatment of LBP and it is valid, reliable. Changes from the baseline will be measured and at 4th week and then at 6th week

    Measured: 6th week

Secondary outcomes (5)
  1. Lumbar Range of Motion

    Bubble Inclinometer. Changes from the baseline will be measured and at 4th week and then at 6th week

    Measured: 6th week

  2. Shirado test: to assess isometric endurance of trunk flexors

    To evaluate "flexor endurance" Patient in supine position asked to raise the lower extremities with 90 degrees flexion at hip and knee joint and also maintain cervical flexion, maintain this position for at least 5 minutes. Changes from the baseline will be measured and at 4th week and then at 6th week

    Measured: 6th week

  3. Ito test: to evaluate isometric endurance of trunk extensors

    To measure "extensor endurance" patient in prone position holding sternum off the treatment table and a small pillow below abdomen to decrease lordosis; and maintaining cervical flexion with pelvic stabilization and gluteal contraction maintain this position for 5 minutes. Changes from the baseline will be measured and at 4th week and then at 6th week

    Measured: 6th week

  4. Lifting endurance

    Progressive Iso inertial lifting evaluation(PILE). Changes from the baseline will be measured and at 4th week and then at 6th week

    Measured: 6th week

  5. Fear Avoidance Belief Questionnaire

    Fear Avoidance Belief Questionnaire (FABQ). Changes from the baseline will be measured and at 4th week and then at 6th week

    Measured: 6th week

Timeline

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

  1. First posted6 Nov 2020
  2. Study start1 Dec 2019
  3. Primary completion20 Dec 2020
  4. Study completion20 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619134
Sponsor's protocol ID
REC/00673 Fariha Altaf
Status last verified
Dec 2020
First submitted
1 Nov 2020
Last updated
29 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gordon R, Bloxham S. A Systematic Review of the Effects of Exercise and Physical Activity on Non-Specific Chronic Low Back Pain. Healthcare (Basel). 2016 Apr 25;4(2):22. doi: 10.3390/healthcare4020022.

    PubMed 27417610
  • Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.

    PubMed 28192789
  • Nijs J, Apeldoorn A, Hallegraeff H, Clark J, Smeets R, Malfliet A, Girbes EL, De Kooning M, Ickmans K. Low back pain: guidelines for the clinical classification of predominant neuropathic, nociceptive, or central sensitization pain. Pain Physician. 2015 May-Jun;18(3):E333-46.

    PubMed 26000680
  • Chang WD, Lin HY, Lai PT. Core strength training for patients with chronic low back pain. J Phys Ther Sci. 2015 Mar;27(3):619-22. doi: 10.1589/jpts.27.619. Epub 2015 Mar 31.

    PubMed 25931693
  • Bhadauria EA, Gurudut P. Comparative effectiveness of lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain: randomized clinical trial. J Exerc Rehabil. 2017 Aug 29;13(4):477-485. doi: 10.12965/jer.1734972.486. eCollection 2017 Aug.

    PubMed 29114516
  • Cho I, Jeon C, Lee S, Lee D, Hwangbo G. Effects of lumbar stabilization exercise on functional disability and lumbar lordosis angle in patients with chronic low back pain. J Phys Ther Sci. 2015 Jun;27(6):1983-5. doi: 10.1589/jpts.27.1983. Epub 2015 Jun 30.

    PubMed 26180363
  • Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. doi: 10.12669/pjms.334.12664.

    PubMed 29067082
  • Inani SB, Selkar SP. Effect of core stabilization exercises versus conventional exercises on pain and functional status in patients with non-specific low back pain: a randomized clinical trial. J Back Musculoskelet Rehabil. 2013;26(1):37-43. doi: 10.3233/BMR-2012-0348.

    PubMed 23411647
  • Ito T, Shirado O, Suzuki H, Takahashi M, Kaneda K, Strax TE. Lumbar trunk muscle endurance testing: an inexpensive alternative to a machine for evaluation. Arch Phys Med Rehabil. 1996 Jan;77(1):75-9. doi: 10.1016/s0003-9993(96)90224-5.

    PubMed 8554479
  • Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

    PubMed 22588748
  • Saur PM, Ensink FB, Frese K, Seeger D, Hildebrandt J. Lumbar range of motion: reliability and validity of the inclinometer technique in the clinical measurement of trunk flexibility. Spine (Phila Pa 1976). 1996 Jun 1;21(11):1332-8. doi: 10.1097/00007632-199606010-00011.

    PubMed 8725925
  • Williamson E. Fear Avoidance Beliefs Questionnaire (FABQ). Aust J Physiother. 2006;52(2):149. doi: 10.1016/s0004-9514(06)70052-6. No abstract available.

    PubMed 16805041
  • Jensen LD, Maribo T, Schiottz-Christensen B, Madsen FH, Gonge B, Christensen M, Frost P. Counselling low-back-pain patients in secondary healthcare: a randomised trial addressing experienced workplace barriers and physical activity. Occup Environ Med. 2012 Jan;69(1):21-8. doi: 10.1136/oem.2010.064055. Epub 2011 May 19.

    PubMed 21597108

Questions about this trial

What is this clinical trial studying?

A study testing NCSR Program and conventional physical therapy in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: 6th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04619134, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.

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