Manual Therapy and Exercise in Low Back Pain

NCT ID: NCT04924387

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-12-23

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?

Detailed Description

Non-specific low back pain is one of the main causes of disability for health care worldwide. Nowadays, the mostly used technique to research low back muscular activity is electromyography.

Among the published studies, 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.

The main objective that is aimed by this thesis, is the evaluation of muscular activation in the reduction of non-specific low back pain through a 12 weeks procedure programme, which includes therapeutic exercise combined with other treatment techniques, and assessing the psycho-social characteristics of pain.

This study's population will be composed by at least 16 individuals per group, both male and female, with ages among 20 and 80.

Participants will be randomly and blindly divided in three groups of intervention. The three groups will be: the experimental group or EXP Group (all participants subject to therapeutic exercise), the experimental group, which will also be subject to manual therapy (MT Group) and finally, the experimental group, which will also be subject to kinesio tape work (KT Group).

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group (EXP group)

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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.

Experimental Group and Manual Therapy (MT Group)

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: 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.

Experimental Group and Kinesio Tape (KT Group)

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: 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.

Interventions

Exercise

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.

Intervention Type: PROCEDURE

Other Intervention Names

musculoskeletal manipulation; kinesiotaping

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Universidad Católica de Valencia San Vicente Mártir

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Vicente Mampel, Phd

Role: STUDY_DIRECTOR

Fundación Universidad Católica de Valencia San Vicente Mártir

Locations

FundacionUCV

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 31631992 (View on PubMed)

Other Identifiers

UCV/2019-2020/138

Identifier Type: -

Identifier Source: org_study_id