Intrasound therapy and transcutaneous electrical nerve stimulation (TENS) in the treatment of osteoarthritis of the knee

ISRCTN	ISRCTN29365316
DOI	https://doi.org/10.1186/ISRCTN29365316
Secondary identifying numbers	N/A

Submission date: 28/03/2015
Registration date: 16/06/2015
Last edited: 12/05/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Osteoarthritis (OA), the most common type of arthritis, is a condition that causes joints to become painful and stiff. OA typically affects the knees, hips and small joints of the hands. OA is an incurable, long term condition but there are a number of treatments available to manage its symptoms, in addition to maintaining a healthy weight and regularly exercising. OA of the knee can often result in disability and make it hard for people to carry out their normal daily activities. It can also make it difficult for people to exercise. Physiotherapists can help people to create an exercise plan to manage their symptoms. They also provide various treatments to reduce pain and swelling in the joints. One such treatment is transcutaneous electrical nerve stimulation (TENS), which is often used to reduce pain in OA. In TENS, electrodes attached to a small, battery-operated machine are placed on the affected body part, such as the knee. When the machine is switched on, electrical signals are sent to the nerves which disrupt the pain signals. There are also various complementary and alternative therapies available to people with OA. Intrasound Therapy (IST) is a complementary therapy which uses sound waves to give pain relief for inflammatory conditions such as OA of the knee. It is a simple device for home use, and some OA sufferers have found that it helps relieve their symptoms. However, IST has not been scientifically tested so we don’t know how well it actually works. This is the first study to test how well IST works in adults with OA of the knee. The aim of this study is to see how well IST works to help patients with OA of the knee manage their pain compared to TENS.

Who can participate?
Adult with OA of the knee

What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 (control group) carry out a range of exercises. Those in group 2 (intervention group) receive IST and carry out a range of exercises. Those in group 3 (intervention group) receive TENS and carry out a range of exercises. Mobility and pain levels are measured before treatment and after 8 weeks of treatment. Participants also complete questionnaires.

What are the possible benefits and risks of participating?
Participants are not exposed to any known risks as the treatments are considered safe to use.

Where is the study run from?
Lagos University Teaching Hospital (Nigeria)

When is the study starting and how long is it expected to run for?
June 2014 to November 2014

Who is funding the study?
Investigator initiated and funded (Nigeria)

Who is the main contact?
Dr A Aiyegbusi (scientific)
aaiyegbusi@unilag.edu.ng

Contact information

Dr Ayoola Aiyegbusi
Scientific

Department of Physiotherapy
College of Medicine, University of Lagos
Lagos
02341
Nigeria

ORCID ID	0000-0002-8052-0908

Study information

Study design	Single-centre preliminary clinical interventional study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Intrasound therapy is an effective adjunct in the management of osteoarthritis of the knee: a preliminary clinical study
Study objectives	Will intrasound therapy be as effective as TENS, a proven physiotherapy modality as an adjunct in the management of osteoarthritis of the knee?
Ethics approval(s)	Health, Research and Ethics Committee of the Lagos University Teaching Hospital, Nigeria, 22/07/2014, ref: ADM/DCST/HREC/1806
Health condition(s) or problem(s) studied	Mild/moderate unilateral osteoarthritis of the knee
Intervention	1. Group 1 (control): closed kinetic chain exercises and range of motion exercises 2. Group 2 (intervention): intrasound therapy for 10 minutes followed by closed kinetic chain exercises and range of motion exercises 3. Group 3 (intervention): TENS for 15 minutes followed by closed kinetic chain exercises and range of motion exercises
Intervention type	Device
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Assessed pre-treatment, at baseline and post-treatment after 8 weeks of intervention: Western Ontario and McMaster Universities (WOMAC) score to assess pain, stiffness and physical function.
Secondary outcome measures	Assessed pre-treatment, at baseline and post-treatment after 8 weeks of intervention: 1. 6-minute walk test 2. Range of motion of the knee
Overall study start date	04/06/2014
Completion date	14/11/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	32
Key inclusion criteria	1. Age 52-76 2. Unilateral OA of the knee
Key exclusion criteria	1. Patients with underlying systemic diseases and other rheumatic conditions of the knee 2. Patients with severe OA using the Kellgren and Lawrence system of classification
Date of first enrolment	29/07/2014
Date of final enrolment	12/09/2014

Locations

Countries of recruitment

Nigeria

Study participating centre

Lagos University Teaching Hospital

Department of physiotherapy
Lagos
Nigeria

Sponsor information

Lagos University Teaching Hospital
Hospital/treatment centre

Health, Research & Ethics Committee
Idiaraba
Lagos
02341
Nigeria

Website	www.luthnigeria.org
"ROR"	https://ror.org/00gkd5869

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	30/03/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Results to be disseminated through peer-reviewed scientific journals and presentation at scientific conferences
IPD sharing plan