Effects of Different Exercise Programs Plus Photobiomodulation on Non-specific Low-back Pain.

NCT04887987 | Completed

• 1 other identifier: Photobiomodulation project
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The present project aims to examine the effects of different exercise programs (Pilates and multicomponent) combined with photobiomodulation therapy (PBMT) on pain intensity, postural balance, perceived disability, kinesiophobia, and pain-related fear of movement in patients with chronic non-specific low back pain (CNLBP). It was hypothesized that the exercise programs plus active PBMT would outperform the exercise program alone (sham PBMT) in improving postural balance, and decreasing pain intensity, perceived disability, kinesiophobia, and pain-related fear of movement in patients with CNLBP.

Conditions

Exercise Training; Photobiomodulation Therapy; Low Back Pain

Keywords

Exercise training; Photobiomodulation therapy; Light-emitting diodes; Low back pain; Perceived disability; kinesiophobia; Pain-related fear of moviment

Outcome Measures

Primary Outcomes (6)

• Peak pain intensity

  Pain severity will be determine using a 10-point numerical rating scale (NRS), with extremities designated as 0 (no pain) to 10 (unbearable pain). Participants will be instructed to draw a vertical line at a scale point that best matched their level of pain throughout the day. Pain intensity was recorded at night (between 7 and 8 p.m.) for the first 3 days before the intervention (basal) and the last 3 days after the intervention.

  Baseline and after 8 weeks

• Tampa Scale of kinesiophobia (TSK)

  The TSK is a 17-item self-report questionnaire designed to assess fear of movement, fear of physical activity, and fear avoidance beliefs in patients with chronic LBP \[1, 2\]. Each item has a 4-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree), with individual scores for items 4, 8, 12, and 16 reversed. The total score is the sum of all items ranging from 17 to 68 points, with higher scores indicating a higher level of kinesiophobia \[2\].

  Baseline and after 8 weeks

• Fear-Avoidance Beliefs Questionnaire (FABQ-Phys)

  The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity (FABQ-Phys) and work may affect and contribute to their low back pain and resulting disability. The FABQ-Phys has four items with a 6-point Likert scale on each, ranging from 0 (strongly disagree) to 6 (strongly agree) \[3, 4\]. The total score is the sum of all items ranging from 0 to 24, with a higher score indicating a higher level of fear and avoidance behavior associated with beliefs about how physical activity affects LBP.

  Baseline and after 8 weeks

• Pain Catastrophizing Scale (PCS)

  PCS is a instrument used for measuring catastrophic thinking related to pain. The PCS is a 13-item scale that measures the effect of LBP on rumination, amplification of pain sensations, and feelings of helplessness to control pain \[5\]. Each item has a 4-point scale ranging from 0 (not at all) to 4 (all the time), on which the participant indicates their level of thoughts and feelings while they are in pain. The total score is the sum of all items on a scale of 0-52 points, with higher scores indicating a higher level of pain catastrophizing \[5\].

  Baseline and after 8 weeks

• Oswestry Disability Index (ODI)

  The ODI is used to assess self-reports of disability caused by LBP \[6, 7\]. The ODI is made up of 10 sections scored from 0 to 5 points, with the total score ranging from 0 to 50 points \[6\]. A higher score indicates a higher level of disability \[6, 8\].

  Baseline and after 8 weeks

• Roland Morris Disability Questionnaire (RMDQ)

  RMDQ questionnaire is designed to assess self-rated physical disability caused by low back pain. The RMDQ consists of 24 items with scores ranging from 0 to 24 points \[6\]. A higher score indicates a higher level of disability \[6, 8\].

  Baseline and after 8 weeks

Secondary Outcomes (1)

• Postural balance

  Baseline and after 8 weeks

Study Arms (4)

Pilates exercise program + active PBMT (PIL+PBMT)

EXPERIMENTAL

Participants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive active PBMT on the lumbar region (between L1 and L5) 10 min before and after exercise sessions (totaling 20 min), through a device containing 264 LEDs (132 red and 132 infrared.

Other: Pilates training + active PBMT

Pilates exercise program + sham PBMT (PIL+SHAM)

SHAM COMPARATOR

Participants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive sham PBMT on the lumbar region (between L1 and L5) 10 min before and after exercise sessions (totaling 20 min), through a device containing 264 LEDs (132 red and 132 infrared.

Other: Pilates training + sham PBMT

Multicomponent exercise program + active PBMT (EX+PBMT)

EXPERIMENTAL

Participants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive active PBMT on the lumbar region (between L1 and L5) imediately before each workout, through a device containing 200 LEDs (100 red and 100 infrared).

Other: Multicomponent training + active PBMT

Multicomponent exercise program + sham PBMT (EX+SHAM)

SHAM COMPARATOR

Participants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive sham PBMT on the lumbar region (between L1 and L5) imediately before each workout, through a device containing 200 LEDs (100 red and 100 infrared).

Other: Multicomponent training + sham PBMT

Interventions

Pilates training + active PBMT OTHER

Participants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive active PBMT on the lumbar region 10 min before and after (totaling 20 min) each workout.

Pilates exercise program + active PBMT (PIL+PBMT)

Pilates training + sham PBMT OTHER

Participants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive sham PBMT on the lumbar region 10 min before and after (totaling 20 min) each workout.

Pilates exercise program + sham PBMT (PIL+SHAM)

Multicomponent training + active PBMT OTHER

Participants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive active PBMT on the lumbar region imediately before each workout.

Multicomponent exercise program + active PBMT (EX+PBMT)

Multicomponent training + sham PBMT OTHER

Participants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive sham PBMT on the lumbar region imediately before each workout.

Multicomponent exercise program + sham PBMT (EX+SHAM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18-75 years
• Self-report of recurrent (≥ 3 x/week) or continuous episodes of nonspecific low back pain for at least 3 months, comprising the lumbar region between L1-L5

You may not qualify if:

• To present a history of musculoskeletal disorders that could affect muscle function
• To make use of medicines that could affect muscle function.
• To present low back pain of specific etiology, such as: tumor, herniated disc, facet syndrome, canal stenosis, among others.
• To have used ergogenic supplements and anabolic steroids for at least six months before study
• To present severe skin diseases in the lumbar region, such as: erysipelas, eczema, dermatitis, psoriasis and urticaria
• To have restrictions for exercises practice considering Physical Activity Readiness Questionnaire (PAR-Q) responses.

Sponsors & Collaborators

• Universidade Norte do Paraná: lead

Study Sites (1)

Universidade Norte do Paraná

Londrina, Paraná, 86.041-140, Brazil

Location

Related Publications (5)

• Hudes K. The Tampa Scale of Kinesiophobia and neck pain, disability and range of motion: a narrative review of the literature. J Can Chiropr Assoc. 2011 Sep;55(3):222-32.

  PMID: 21886284 RESULT

• Lundberg M, Styf J, Jansson B. On what patients does the Tampa Scale for Kinesiophobia fit? Physiother Theory Pract. 2009 Oct;25(7):495-506. doi: 10.3109/09593980802662160.

  PMID: 19925172 RESULT

• Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.

  PMID: 8455963 RESULT

• Jacob T, Baras M, Zeev A, Epstein L. Low back pain: reliability of a set of pain measurement tools. Arch Phys Med Rehabil. 2001 Jun;82(6):735-42. doi: 10.1053/apmr.2001.22623.

  PMID: 11387576 RESULT

• Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.

  PMID: 11124727 RESULT

MeSH Terms

Conditions

Low Back Pain; Kinesiophobia

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 17, 2021
• Study Start: February 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: November 30, 2022
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)