Pulse Ultrasound and Kneading Massage in Non- Specific Chronic Low Back Pain

NCT03329482 | Completed

• 1 other identifier: ObafemiAU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Back pain is one of humanity most frequent complains. About nine of ten adults experience back pain at some points in their life and five out of ten working adults have back pain every year. When continued for long period it may constitute a disability which tries the patient of the most stoical individual as well as the doctor called to bring relief to the suffering victim. Kneading massage with topical analgesic is a common practice by physiotherapist especially in Nigeria in the management of low back pain, work has been done to know the efficacy of lofnac gel (topical analgesic) via phonophoresis in the management of low back pain(ojoawo,2015), but the comparison of the efficacy of kneading massage and phonophoresis in the management of low back pain has not been well documented. The purpose of this study therefore, is to compare the efficacy of kneading massage and phonophoresis using lofnac gel in the treatment of non-specific chronic low back pain.

Conditions

Non Specific Low Back Pain

Keywords

Ultrasound; kneading-massage; low back pain; pain intensity; disability

Outcome Measures

Primary Outcomes (1)

• The verbal rating scale

  The verbal rating scale is a 10-point rating scale that measures present pain intensity of patients. The scale started from 0 and ends with 10. 0 indicate no pain, 1 indicate minimal pain while 5 indicates moderate pain and 10 indicates the most difficult pain called excruciating pain

  6 Weeks

Secondary Outcomes (1)

• Roland Morris Disability Questionnaire

  6 weeks

Study Arms (2)

Pulse Ultrasound Group A

EXPERIMENTAL

This is the Pulse Ultrasound group. Twenty five patients will be in this group.

Other: PULSE ULTRASOUND

Kneading Massage Group B

EXPERIMENTAL

This is kneading massage group . Also 25 patients will be in this group.

Other: KNEADING MASSAGE

Interventions

PULSE ULTRASOUND OTHER

For group A, The PUS group received pulse mode of ultrasound (sonoplus 490s), with frequency of 1MHZ and intensity of 1.5w/cm according to Ebadi et al 10). Grey's formula was used to estimate the duration of ultrasound (US) for each patient 21). The average local exposure time was one minute and the effective radiating area of the transducer head was 5 cm2. For a patient with an area of low back pain of 40 cm2, the required total treatment time was: 1 min × (40 cm2/5 cm2) = 8 minutes. US was applied using slow circular movements, with the transducer head placed over the painful paravertebral low back region and Lofnac gel used as coupling medium.

Also known as: ULTRASOUND

Pulse Ultrasound Group A

KNEADING MASSAGE OTHER

Kneading massage was done with the two hands maintaining a slow circular compression of soft tissues against underlying bone. Pressure was applied as the hands moved proximally, continuously maintaining a contact with the skin, according to Goat22). Lofnac gel was used as a coupling medium for the massage. This was done for an approximately ten and 12 minutes.

Also known as: MASSAGE

Kneading Massage Group B

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mechanical low back pain who have had pain for more than three months were eligible for the study.

You may not qualify if:

• Patients with nerve roots symptoms, underlying systemic or viscera disease and specific condition such as neoplasm, fracture, ankylosing spondylolytis, previous low back surgery and pregnancy were excluded

Sponsors & Collaborators

• Obafemi Awolowo University: lead

Study Sites (1)

Obafemi Awolowo University

Ile-Ife, Osun State, 220005, Nigeria

Location

Related Publications (3)

• Ebadi S, Ansari NN, Naghdi S, Jalaei S, Sadat M, Bagheri H, Vantulder MW, Henschke N, Fallah E. The effect of continuous ultrasound on chronic non-specific low back pain: a single blind placebo-controlled randomized trial. BMC Musculoskelet Disord. 2012 Oct 2;13:192. doi: 10.1186/1471-2474-13-192.

  PMID: 23031570 BACKGROUND

• Goats GC. Massage--the scientific basis of an ancient art: Part 1. The techniques. Br J Sports Med. 1994 Sep;28(3):149-52. doi: 10.1136/bjsm.28.3.149.

  PMID: 8000809 BACKGROUND

• Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.

  PMID: 16000093 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

High-Energy Shock Waves; Massage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: One of the Physiotherapist who carried out the assessment especially when the intervention started did not aware of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A total number of 50 subjects were enrolled for the study: 25 subjects for the PUS group and 25 subjects for the KM group in order to give room for attrition. For the purpose of the study the following instruments were used: verbal-rating scale, Roland-Morris disability questionnaire, and an ultrasound machine

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: August 12, 2016
• Primary Completion: April 15, 2017
• Study Completion: April 15, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)