Effects of Core Exercise in Low Back Pain

NCT05544890 | Completed

• 1 other identifier: UCV/2019-2020/138
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Non-specific low back pain in one of the main causes of disability for health care worldwide. The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover, can these techniques be combined?

Conditions

Low Back Pain

Keywords

Chronic pain; Muskuloskeletal manipulation; Complementary therapies; Catastrophization; Kinesiophobia

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index.

  The Oswestry Disability Index (ODI) test will be made to all participants at three months. Divided into 10 sections (each is scored from zero to five, with higher scores meaning higher disability), it is self-administered to assess the limitations of different activities of daily living. That is why, it has been established that all participants in Stage 2 of the test are subsidiaries to make all the treatment modes of the study (manual therapy, kinesiotape and exercise). This way, we are able to rise the homogeneity that imposes a diagnostic label such as the chronic low back pain.

  12 weeks

Secondary Outcomes (6)

• Catastrophism (PCS)

  12 weeks

• Kinesiophobia (TKS)

  12 weeks

• Visual analog scale (VAS)

  12 weeks

• Self-efficacy:questionnaire

  12 weeks

• Pressure pain threshold

  12 weeks

Study Arms (3)

Therapeutic exercise Group (ET)

ACTIVE COMPARATOR

The ET group is going to follow a program of core stabilization through specific therapeutic exercise. Two weekly sessions will be programmed for 12 weeks, making a total of 24 sessions. Each session will have a duration of 60 minutes. All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes.

Procedure: Exercise

Manual Therapy group (ETmanualtherapy)

ACTIVE COMPARATOR

Prior the core exercise previously exposed in group ET, group ETmanualtherapy will lay on the stretcher, where the physiotherapist will work on a manual therapy thrust. The participant will receive a high velocity and low range impulse technique in lateral position on both sides.

Procedure: Exercise; Procedure: Manual Therapy

Kinesiotape Group (ETkinesiotape)

ACTIVE COMPARATOR

The ETkinesiotape will go previously through physiotherapy, where a kinesiotape band will be applied (Kinesiotape "Nondolens" 5cmx5cm black color), in Y technique, by applying the kinesiotape base in neutral position of the lumbar spine without any tension on the tape. The participants realize the same exercise program than the other groups plus the kinesiotape applied.

Procedure: Exercise; Procedure: Kinesiotape

Interventions

Exercise PROCEDURE

All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: \- Therapeutic exercise

Kinesiotape Group (ETkinesiotape); Manual Therapy group (ETmanualtherapy); Therapeutic exercise Group (ET)

Manual Therapy PROCEDURE

All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: \- Manipulation

Manual Therapy group (ETmanualtherapy)

Kinesiotape PROCEDURE

All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: \- Kinesiotaping

Kinesiotape Group (ETkinesiotape)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical diagnosis of CLBP confirmed by an orthopaedic specialist Classification at Stage 2 by ODI Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids.

You may not qualify if:

• Previous or scheduled surgeries in the low back and abdominal area
• Presence of severe fractures or pathologies.
• Diagnosis of radiculopathy or neuropathy (with or without spinal canal stenosis).
• Structural deformity in the spinal column.
• Neurological or psychiatric disorder.
• Presence or suspicion of pregnancy.

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Universitat Jaume I

Castellon, Castellón, 12071, Spain

Location

Related Publications (9)

• Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.

  PMID: 24665116 BACKGROUND

• Finucane LM, Downie A, Mercer C, Greenhalgh SM, Boissonnault WG, Pool-Goudzwaard AL, Beneciuk JM, Leech RL, Selfe J. International Framework for Red Flags for Potential Serious Spinal Pathologies. J Orthop Sports Phys Ther. 2020 Jul;50(7):350-372. doi: 10.2519/jospt.2020.9971. Epub 2020 May 21.

  PMID: 32438853 BACKGROUND

• Pitcher MH, Von Korff M, Bushnell MC, Porter L. Prevalence and Profile of High-Impact Chronic Pain in the United States. J Pain. 2019 Feb;20(2):146-160. doi: 10.1016/j.jpain.2018.07.006. Epub 2018 Aug 7.

  PMID: 30096445 BACKGROUND

• Ketenci A, Zure M. Pharmacological and non-pharmacological treatment approaches to chronic lumbar back pain. Turk J Phys Med Rehabil. 2021 Mar 4;67(1):1-10. doi: 10.5606/tftrd.2021.8216. eCollection 2021 Mar.

  PMID: 33948537 BACKGROUND

• Kreiner DS, Matz P, Bono CM, Cho CH, Easa JE, Ghiselli G, Ghogawala Z, Reitman CA, Resnick DK, Watters WC 3rd, Annaswamy TM, Baisden J, Bartynski WS, Bess S, Brewer RP, Cassidy RC, Cheng DS, Christie SD, Chutkan NB, Cohen BA, Dagenais S, Enix DE, Dougherty P, Golish SR, Gulur P, Hwang SW, Kilincer C, King JA, Lipson AC, Lisi AJ, Meagher RJ, O'Toole JE, Park P, Pekmezci M, Perry DR, Prasad R, Provenzano DA, Radcliff KE, Rahmathulla G, Reinsel TE, Rich RL Jr, Robbins DS, Rosolowski KA, Sembrano JN, Sharma AK, Stout AA, Taleghani CK, Tauzell RA, Trammell T, Vorobeychik Y, Yahiro AM. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain. Spine J. 2020 Jul;20(7):998-1024. doi: 10.1016/j.spinee.2020.04.006. Epub 2020 Apr 22.

  PMID: 32333996 BACKGROUND

• Toomey D, Reid D, White S. How manual therapy provided a gateway to a biopsychosocial management approach in an adult with chronic post-surgical low back pain: a case report. J Man Manip Ther. 2021 Apr;29(2):107-132. doi: 10.1080/10669817.2020.1813472. Epub 2020 Sep 15.

  PMID: 32930642 BACKGROUND

• Hayden JA, Ellis J, Ogilvie R, Stewart SA, Bagg MK, Stanojevic S, Yamato TP, Saragiotto BT. Some types of exercise are more effective than others in people with chronic low back pain: a network meta-analysis. J Physiother. 2021 Oct;67(4):252-262. doi: 10.1016/j.jphys.2021.09.004. Epub 2021 Sep 16.

  PMID: 34538747 BACKGROUND

• Vicente-Mampel J, Blanco-Gimenez P, Barrios C. Influence of patient-reported outcomes on the effect of exercise therapy, manual therapy, and kinesiotaping in chronic low back pain: secondary statistical analysis. Sci Rep. 2025 Nov 3;15(1):38400. doi: 10.1038/s41598-025-22260-3.

  PMID: 41184444 DERIVED

• Blanco-Gimenez P, Vicente-Mampel J, Gargallo P, Baraja-Vegas L, Bautista IJ, Ros-Bernal F, Barrios C. Clinical relevance of combined treatment with exercise in patients with chronic low back pain: a randomized controlled trial. Sci Rep. 2024 Jul 24;14(1):17042. doi: 10.1038/s41598-024-68192-2.

  PMID: 39048701 DERIVED

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Kinesiophobia

Interventions

Exercise; Musculoskeletal Manipulations; Athletic Tape

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)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Officials

• Paula Blanco, PDI

  Doctoral School. Catholic University of Valencia San Vicente Mártir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The groups will be arranged randomly and the masking technique to be used will be the doble blind procedure. The subjects will be randomly selected through the EPIDAT 4.2 program. The random allocation to each group will be made just by one external researcher, this way, neither the main researcher, nor the participants, will know their allocation. Furthermore, the inspector who will collect the evaluation data won´t know the allocation of each subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 19, 2022
• Study Start: September 20, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 23, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)