Manual Therapy and Exercise in Low Back Pain

NCT04924387 | Completed

• 1 other identifier: UCV/2019-2020/138
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Non-specific low back pain is 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; manipulation, musculoskeletal; catastrophisation; kinesiotaping; exercise

Outcome Measures

Primary Outcomes (1)

• Oswestry

  The Oswestry (ODI) test will be made to all participants at three months. The results of this scale will provide the necessary information to know the degree of symptomatology of the patient and will therefore help in the planification and procedure to the patient. That is why, it has been established that all participants in Stage 1 of the test are subsidiaries to make all the treatment modes of the study (manual therapy 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)

• Kinesiophobia (TKS)

  (12 weeks)

• Catastrophism (PCS)

  (12 weeks)

• Self-efficacy: questionnaire

  (12 weeks)

• Visual analog scale (VAS)

  (12 weeks)

• Pressure algometry

  (12 weeks)

Study Arms (3)

Experimental Group (EXP group)

EXPERIMENTAL

The experimental group (EXP Group) is going to follow a programme of stabilisation through specific therapeutic exercises of the lumbopelvic centre. Two weekly sessions will be programmed for 12 weeks, making a total of 24 sessions. Each sesión will have a duration of 60 minutes, the first 5 minutes for a warm-up and the last 10 for a cool-down phase of active stretching. All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. The exercices will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rests between series will be of 30 seconds, and between exercies of 2-3 minutes.

Procedure: Exercise

Experimental Group and Manual Therapy (MT Group)

ACTIVE COMPARATOR

Additionally to the core exercises previously exposed in Group EXP, Group MT will lay on the stretcher first, where the physiotherapist will work on a manual therapy thrust. The patient will receive an impulse technique in lateral decubitus position, with high velocity and low range on both sides.

Procedure: Exercise

Experimental Group and Kinesio Tape (KT Group)

ACTIVE COMPARATOR

The experimental group plus kinesio tape (KT Group) will go previously through physiotherapy, where a kinesio tape band will be applied (kinesio tape "Nondolens" 5cm x 5cm black color), in Y technique, by applying the KT base in neutral position of the lumbar spine without any tension on the tape.

Procedure: Exercise

Interventions

Exercise PROCEDURE

All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. 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 rests between series will be of 30 seconds, and between exercises of 2-3 minutes.

Also known as: musculoskeletal manipulation, kinesiotaping

Experimental Group (EXP group); Experimental Group and Kinesio Tape (KT Group); Experimental Group and Manual Therapy (MT Group)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with low back pain.
• Patients who are in Stage 1 of the Oswestry scale.
• Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids
• Be able to understand the exercises and spanish language.

You may not qualify if:

• Having any back surgery.
• Be taking any medication at the time of the study.
• Have a pathology in which exercise is contraindicated (spondylolisthesis, spondylolysis, spondyloarthrosis).
• Be in a state of gestation or if there is the possibility of being.
• Present or have presented some oncological process.

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (1)

FundacionUCV

Valencia, Spain

Location

Related Publications (1)

• Ozsoy G, Ilcin N, Ozsoy I, Gurpinar B, Buyukturan O, Buyukturan B, Kararti C, Sas S. The Effects Of Myofascial Release Technique Combined With Core Stabilization Exercise In Elderly With Non-Specific Low Back Pain: A Randomized Controlled, Single-Blind Study. Clin Interv Aging. 2019 Oct 9;14:1729-1740. doi: 10.2147/CIA.S223905. eCollection 2019.

  PMID: 31631992 RESULT

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Motor Activity

Interventions

Exercise; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Juan Vicente Mampel, Phd

  Fundación Universidad Católica de Valencia San Vicente Mártir

  STUDY DIRECTOR

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 the double blind procedure. The subjects will be randomly selected through the GPower 3.1 programme. 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 either the allocation of each subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: June 14, 2021
• Study Start: March 1, 2021
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)