Condition category
Musculoskeletal Diseases
Date applied
19/11/2007
Date assigned
10/04/2008
Last edited
27/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Nearly half of all adults in the UK have had back pain at some point in their lives making it a very common and costly problem. The United Kingdom Office for National Statistics report that three and a half million adults suffer with back pain the entire year. Fourteen to fifteen million GP consultations every year in the UK are due to back pain. Back pain costs the UK approximately £10668 million accounting for 13.5% of all incapacity benefits. Whilst there are many types of treatment for back pain, one that helps everyone has not yet been found.
Kinesiology is a relatively new and increasingly popular alternative treatment. It originated in the 1960’s in America from a chiropractic technique and became known as Applied Kinesiology. Applied Kinesiology is practiced by some doctors, dentists and chiropractors. Since then many other types of kinesiology have been developed and the practice has spread to over 50 countries.
Kinesiopractic®, otherwise known as Professional Kinesiology Practice (PKP) was developed from Applied Kinesiology in the 1980’s by a New Zealand medical doctor.
Many people who have tried PKP for back pain say it helped them. Our goal was to do a study to find out if there was any scientific evidence that PKP could help back pain.

Who participated?
The participants in our study were men and women aged between 18 – 65 who had been diagnosed by their GP with low back pain. We included people who had chronic low back pain (pain that had lasted for at least 3 months or more) but were otherwise well and not taking any medication except for pain killers. In order to compare the treatments properly we had to make sure that everyone in the trial had a similar type of back pain. To do this we excluded some people from our study for example people who had already had surgery for their back pain, were waiting for surgery or had pain in another part of their back e.g. upper back.

What did the study involve?
In order to check eligibility for the trial we asked interested people to call us and answer a few questions about their pack pain over the phone. People who appeared to have the type of back pain we were looking for were then invited to the clinic to complete some questionnaires about their back pain. If the questionnaires confirmed they had the right type of back pain we asked people to consent to participating and we then made appointments with them to come for kinesiology treatment.
The participants came to the kinesiology centre once a week for 5 weeks to have their kinesiology treatment. They completed some questionnaires each time about how their back pain had been during the previous week which helped us find out if the treatment was helping.
Everyone in the study received kinesiology treatment. We wanted to test 2 types of kinesiology for back pain to see which was best. The statistician placed our participants into 3 treatment groups using a process called randomization which is rather like a coin toss. Only the practitioner knew which group each person was in. People received either traditional PKP or another type of kinesiology treatment. The people in the first two groups started their treatment straight away and people in the third group started their treatment a bit later.
Seven weeks after kinesiology treatment had finished, people completed a final set of questionnaires by post to help us find out if there were any lasting improvements.

What were the possible benefits and risks of participating?
The benefits we hoped that everyone would receive from the treatments were less pain, more flexibility, a general feeling of wellness and to be able to do more. There are no serious side effects with kinesiology as it is a very safe treatment and none were reported. Three people in our study felt a bit tired and achy after treatment but this only lasted about 24 hours or less. In complementary medicine these effects are quite common and are thought to indicate that the treatment is helping.

Where was the study run from?
The study took place in a private kinesiology office in Surrey.

When did the study start and how long did it run for?
The trial took place during 2008 – 2009 and ran for 12 months

Who funded the study?
We didn’t receive any funding for the study.

Who was the main contact?
Dr Susan Eardley
S.Eardley@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof George Lewith

ORCID ID

Contact details

University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Null hypothesis:
Kinesiology for back pain, as assessed by a reduction of 2.5 points on the Roland Morris Disability Scale after five weeks of treatment is not different from control.

Ethics approval

Ethical approval was granted by South West Surrey Local Regional Ethics Committee on the 6th August 2004 (ref: 04/Q1909/22).

Study design

A single blind, single centre, randomised controlled pilot study with initial feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic and recurrent low back pain

Intervention

1. Real kinesiolology: five treatments - once a week for five weeks
2. Sham kinesiology: five treatments - once a week for five weeks
3. Waiting control: six-week wait then re-randomised to either real or sham kinesiology - five treatments, once a week for five weeks

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Back pain disability measured on the Roland Morris Disability Scale, a 24 item tick questionnaire where a score of at least four points indicates a clinical problem suficient to measure change and a reduction of 2.5 after treatment indicates clinical change. Data collected at baseline, end of treatment and follow up.

Secondary outcome measures

1. 36-item short form health survey (SF-36): a global quality of life scale - 11 questions measuring physical function, role limitation, mental health, vitality, pain and general health, measured at baseline, end of treatment and follow up
2. Visual Analogue Scale (VAS) for pain (0 - 10) (0 = no pain, 10 = worst imaginable pain), measured at baseline, end of treatment and follow up
3. Patient Enablement Instrument (a measure of patient enablement): six questions asking how the patient feels about coping with life after the consultation - scored on a four-point scale, measured at end of treatment
4. Consultation and Relational Empathy (CARE) (a measure of empathy): 11 questions scored on a six-point scale - how did the patient feel the practitioner was at making them feel at ease, etc., measured at end of treatment
5. Measure Yourself Medical Outcome Profile (MYMOP) (a patient rating of their chosen symptoms) comprises four items, scored by the patient on a seven point scale. The first two items are for symptoms that the patient decides are most important to them and the other items relate to daily activities and general well-being, measured at baseline, end of treatment and follow up
6. Holistic Complementary and Alternative Medicine Questionnaire (HCAMQ) (a measure of beliefs about complementary medicine): 17 questions asking about the patients beliefs about health and treatment, measured at baseline, end of treatment and follow up
7. Credibility/expectancy questionnaire: six questions asking how much the patient believes the treatment will help their condition, measured at end of treatment

Overall trial start date

01/09/2007

Overall trial end date

31/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 - 65 years, male and female
2. Chronic or recurrent non-specific low back pain (lower ribs to gluteal folds)
3. Previous episode of pain at least three months previously (constitutes a recurrent problem)
4. Current pain for the last three weeks (excludes short lived occurrence)
5. Roland Morris Disability scale score of greater than or equal to four (constitutes a clinical problem)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Under 18 years or over 65 (serious spinal pathology more likely)
2. Currently undergoing other treatment for back pain other than analgesics (other treatment may have carry-over effect) - six weeks washout required
3. Previous kinesiology (naivety required as a sham treatment is involved)
4. Serious spinal pathology or systemic illness (outside scope of study)
5. Psychosis or alcohol abuse (completion of forms, safety of practitioner)
6. Disability of limbs, inability to lie on or get on and off an examination couch (for purpose of muscle testing)
7. Weigh more than 15 stone (safety limit of examination table)
8. Litigation pending due to back pain or receiving disability allowance due to back pain (potential treatment resistance until monies received or stopped)
9. Previous spinal operation or waiting for same (outcome likely to be different). Facet joint injections are accepted because the spinal anatomy remains the same.

Recruitment start date

01/09/2007

Recruitment end date

31/01/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

The University of Southampton (UK)

Sponsor details

Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
S.S.Hall@soton.ac.uk

Sponsor type

University/education

Website

http://www.soton.ac.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19142041

Publication citations

  1. Results

    Hall S, Lewith G, Brien S, Little P, An exploratory pilot study to design and assess the credibility of a sham kinesiology treatment., Forsch Komplementmed, 2008, 15, 6, 321-326, doi: 10.1159/000170401.

Additional files

Editorial Notes