The effectiveness of manual therapy or pulsed shortwave diathermy (PSWD) in addition to exercise and advice for neck disorders; a pragmatic study in physiotherapy clinics
| ISRCTN | ISRCTN77535030 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77535030 |
| Secondary identifying numbers | D0566 |
- Submission date
- 15/07/2002
- Registration date
- 15/07/2002
- Last edited
- 05/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Krysia Dziedzic
Scientific
Scientific
Primary Care Sciences Research Centre
Keele University
Keele
ST5 5BG
United Kingdom
| Phone | +44 (0)1782 583907 |
|---|---|
| k.s.dziedzic@cphc.keele.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | The PANTHER study |
| Study objectives | To determine whether manual therapy or pulsed shortwave diathermy (PSWD), in addition to advice and exercise, provide better clinical outcome at six months than advice and exercise alone in primary care patients with nonspecific neck disorders. |
| Ethics approval(s) | Ethical approval was granted by the West Midlands Multicenter Research Ethics Committee and 10 local Research Ethics Committees. |
| Health condition(s) or problem(s) studied | Non-specific neck pain |
| Intervention | 1. Manual therapy: defined as hands-on, passive or active assisted movements/mobilisations, graded as appropriate to the patient's signs and symptoms 2. PSWD: delivered according to the best available evidence appropriate for UK clinical practice. It is not prescriptive but incorporates professional guidelines to good practice. 3. No additional treatment to advice and exercise All subjects receive a standard package of home exercises, advice and an information leaflet about care of their neck based on the ARC publication. Further management of the patients in the no manual therapy/no PSWD group is based on this information. |
| Intervention type | Other |
| Primary outcome measure | Change in self-reported neck pain related disability at six months as measured on the Northwick Park Neck Pain Questionnaire. |
| Secondary outcome measures | 1. Participants' global assessment of change compared with baseline 2. Average pain severity over the past three days 3. Severity rating of main problem 4. Number of days lost from paid employment 5. Co-interventions e.g. visits to general practitioner (GP), use of analgesia 6. Quality of life (EuroQoL EQ-5D) and 12-item short form health survey (SF-12) |
| Overall study start date | 01/09/2000 |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 350 |
| Key inclusion criteria | 1. Males and females aged 18 years and over 2. Clinical diagnosis of neck pain and/or stiffness, including unilateral referred pain into the arm 3. No consultations for this problem with health care professionals other than the Primary Health Care Team in the previous six months 4. Ability to understand and to cooperate and capable of giving written informed consent |
| Key exclusion criteria | 1. Weight loss 2. Fever 3. Progressive neurological signs including bilateral arm pain 4. Evidence of muscle weakness or disturbance in normal sensation 5. History of malignancy 6. Inflammatory arthritis 7. Polymyalgia rheumatica 8. Osteoporosis or gross structural or neurological abnormality affecting the neck 9. Contra-indications to the study treatments (e.g. patients on anti-coagulants) 10. Any injury awaiting a compensation claim (e.g. deceleration or industrial injury) 11. Pregnancy |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Primary Care Sciences Research Centre
Keele
ST5 5BG
United Kingdom
ST5 5BG
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom
| Phone | +44 (0) 300 790 0400 |
|---|---|
| enquiries@arthritisresearchuk.org | |
| Website | http://www.arc.org.uk |
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 15/04/2005 | Yes | No |
