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Effectiveness of Manual Therapy in Non-specific Low Back Pain

Primary Purpose

Physiotherapy Specialty, Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

dry needling

ischemic compression

About this trial

This is an interventional treatment trial for Physiotherapy Specialty focused on measuring dry needling, low back pain, physiotherapy specialty, pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent form.
Presence of non-specific low back pain for more than six weeks.
Presence of a palpable tight band nodule in the gluteus medius muscle.
Presence of a hypersensitive or hyperirritable point in the tight band.
Patients reporting local or referred pain in the area of the latent MGP after mechanical stimulation mechanical stimulation.

Exclusion Criteria:

Surgeries in the lumbopelvic region.
Diagnosis of herniated discs in the lumbar region.
Positive cognitive screening according to the Pfeiffer questionnaire.
Heterometrics.
Age outside the range of 18 to 75 years.
Ingested or injected anticoagulant or antiplatelet drugs.
Systemic or local infection in the lumbar region.
Pregnancy.
Presence of fear of needles (belonephobia).

Sites / Locations

Universidad Católica de Ávila

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dry needling group

ischaemic compression group

Arm Description

Outcomes

Primary Outcome Measures

Pain

Visual Scale Analogue (0 minimum, 10 maximum).

Secondary Outcome Measures

movement

Schober test (0 minimum, 45 maximun).

quality of life

Oswestry low back pain disability scale (0 minimum, 100% maximum; Between 0-20% minimal limitation or disability, 21-40% moderate limitation or disability, 41- 60% severe limitation or disability, 61-80% disabled and above 81% limitation or disability. 60% severe limitation or disability, 61-80% disabled and above 81% maximum functional limitation or disability, 61-80% disabled and above 81% maximum functional limitation or disability. maximum functional limitation).

Full Information

NCT ID

NCT05440253

First Posted

June 23, 2022

Last Updated

August 11, 2022

Sponsor

Universidad Católica de Ávila

1. Study Identification

Unique Protocol Identification Number

NCT05440253

Brief Title

Effectiveness of Manual Therapy in Non-specific Low Back Pain

Official Title

Effectiveness of Dry Needling VS Ischaemic Compression on Latent Myofascial Myofascial Trigger Points in the Gluteus Medius in Patients With Patients With Non-specific Low Back Pain: a Randomised Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

May 29, 2022 (Actual)

Study Completion Date

June 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Católica de Ávila

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Low back pain affects many people and involves high medical costs. For this reason, we wish to test the efficacy of dry needling VS ischaemic compression in patients with non-specific low back pain. To this end, an investigation was carried out on 40 patients diagnosed with this ailment, divided into two groups by randomisation to assess the intensity of pain, range of movement, pain threshold to pressure and quality of life, measuring these variables prior to the intervention, immediately, at 48 hours and one week after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Physiotherapy Specialty, Low Back Pain

Keywords

dry needling, low back pain, physiotherapy specialty, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dry needling group

Arm Type

Experimental

Arm Title

ischaemic compression group

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

dry needling

Intervention Description

Dry needling of the trigger point of the gluteus medius in patients diagnosed with non-specific low back pain.

Intervention Type

Procedure

Intervention Name(s)

ischemic compression

Intervention Description

Ischaemic trigger point compression of the gluteus medius in patients diagnosed with non-specific low back pain.

Primary Outcome Measure Information:

Title

Pain

Description

Visual Scale Analogue (0 minimum, 10 maximum).

Time Frame

1 week

Secondary Outcome Measure Information:

Title

movement

Description

Schober test (0 minimum, 45 maximun).

Time Frame

1 week

Title

quality of life

Description

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent form. Presence of non-specific low back pain for more than six weeks. Presence of a palpable tight band nodule in the gluteus medius muscle. Presence of a hypersensitive or hyperirritable point in the tight band. Patients reporting local or referred pain in the area of the latent MGP after mechanical stimulation mechanical stimulation. Exclusion Criteria: Surgeries in the lumbopelvic region. Diagnosis of herniated discs in the lumbar region. Positive cognitive screening according to the Pfeiffer questionnaire. Heterometrics. Age outside the range of 18 to 75 years. Ingested or injected anticoagulant or antiplatelet drugs. Systemic or local infection in the lumbar region. Pregnancy. Presence of fear of needles (belonephobia).

Facility Information:

Facility Name

Universidad Católica de Ávila

City

Ávila

ZIP/Postal Code

05005

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

11472684

Citation

Martinez de la Iglesia J, Duenas Herrero R, Onis Vilches MC, Aguado Taberne C, Albert Colomer C, Luque Luque R. [Spanish language adaptation and validation of the Pfeiffer's questionnaire (SPMSQ) to detect cognitive deterioration in people over 65 years of age]. Med Clin (Barc). 2001 Jun 30;117(4):129-34. doi: 10.1016/s0025-7753(01)72040-4. Spanish.

Results Reference

background

PubMed Identifier

8873236

Citation

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Results Reference

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PubMed Identifier

34831877

Citation

Perez-Palomares S, Jimenez-Sanchez C, Serrano-Herrero I, Herrero P, Calvo S. Is Instrumental Compression Equally Effective and Comfortable for Physiotherapists and Physiotherapy Students than Manual Compression? A Comparative Cross-Sectional Study. Int J Environ Res Public Health. 2021 Nov 18;18(22):12121. doi: 10.3390/ijerph182212121.

Results Reference

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PubMed Identifier

19748402

Citation

Aguilera FJ, Martin DP, Masanet RA, Botella AC, Soler LB, Morell FB. Immediate effect of ultrasound and ischemic compression techniques for the treatment of trapezius latent myofascial trigger points in healthy subjects: a randomized controlled study. J Manipulative Physiol Ther. 2009 Sep;32(7):515-20. doi: 10.1016/j.jmpt.2009.08.001.

Results Reference

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PubMed Identifier

11124727

Citation

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. Erratum In: Spine 2001 Apr 1;26(7):847.

Results Reference

result

PubMed Identifier

30368339

Citation

Martin-Pintado-Zugasti A, Mayoral Del Moral O, Gerwin RD, Fernandez-Carnero J. Post-needling soreness after myofascial trigger point dry needling: Current status and future research. J Bodyw Mov Ther. 2018 Oct;22(4):941-946. doi: 10.1016/j.jbmt.2018.01.003. Epub 2018 Jan 17.

Results Reference

result

PubMed Identifier

26406209

Citation

Martin-Pintado-Zugasti A, Rodriguez-Fernandez AL, Fernandez-Carnero J. Postneedling soreness after deep dry needling of a latent myofascial trigger point in the upper trapezius muscle: Characteristics, sex differences and associated factors. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):301-308. doi: 10.3233/BMR-150630.

Results Reference

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PubMed Identifier

24725800

Citation

Ziaeifar M, Arab AM, Karimi N, Nourbakhsh MR. The effect of dry needling on pain, pressure pain threshold and disability in patients with a myofascial trigger point in the upper trapezius muscle. J Bodyw Mov Ther. 2014 Apr;18(2):298-305. doi: 10.1016/j.jbmt.2013.11.004. Epub 2013 Nov 9.

Results Reference

result

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Effectiveness of Manual Therapy in Non-specific Low Back Pain

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