Condition category
Musculoskeletal Diseases
Date applied
15/07/2002
Date assigned
15/07/2002
Last edited
05/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Krysia Dziedzic

ORCID ID

Contact details

Primary Care Sciences Research Centre
Keele University
Keele
ST5 5BG
United Kingdom
+44 (0)1782 583907
k.s.dziedzic@cphc.keele.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D0566

Study information

Scientific title

Acronym

The PANTHER study

Study hypothesis

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

Ethical approval was granted by the West Midlands Multicenter Research Ethics Committee and 10 local Research Ethics Committees.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2000

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

350

Participant 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

Recruitment start date

01/09/2000

Recruitment end date

31/12/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Sciences Research Centre
Keele
ST5 5BG
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom
+44 (0) 300 790 0400
enquiries@arthritisresearchuk.org

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (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

2005 Results in http://www.ncbi.nlm.nih.gov/pubmed/15818640

Publication citations

  1. Results

    Dziedzic K, Hill J, Lewis M, Sim J, Daniels J, Hay EM, Effectiveness of manual therapy or pulsed shortwave diathermy in addition to advice and exercise for neck disorders: a pragmatic randomized controlled trial in physical therapy clinics., Arthritis Rheum., 2005, 53, 2, 214-222, doi: 10.1002/art.21087.

Additional files

Editorial Notes