Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities

Neck Pain Clinical Trial

Official title:

Effectiveness of a Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457496
• Other study ID #: 5147SD2003.0271
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2007
• Last updated: July 11, 2008
• Start date: March 2005
• Est. completion date: April 2006

Study information

• Verified date: July 2008
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the effectiveness of a workplace cognitive and physical program (Intervention), in reducing the frequency of head and neck pain

Description:

Many studies have been performed to assess the efficacy of non invasive physical interventions in the treatment of different types of headache and cervical pain. However the evidence on their effectiveness is still limited and the results of recent studies are conflicting.

The primary objective of this study is to evaluate the effectiveness of a workplace cognitive and physical programme (Intervention) in reducing the frequency of pain involving the head and neck area. The Intervention consists of brief shoulder and neck exercises to be performed several times a day, a relaxation exercise and instructions of how to reduce parafunction and hyperfunction of the craniofacial and cervical muscles during the day.

Comparison(s): Group of employees that will receive a cognitive/physical programme (Intervention), compared to a similar group of employees that will not receive the Intervention (Controls); (frequency of headache and neck and shoulder pain).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects employed at the Municipality of Turin ( Registry-Tax office) from the 1th January 2005 that will give informed consent before starting the study.

Exclusion Criteria:

• Because of the pragmatic design, no exclusion criteria are required for this study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Neck Pain
• Shoulder Pain

Intervention

Behavioral:
• Cognitive, behavioral, exercise
Relaxation exercises once a day, visual feedback, exercises for neck and shoulder

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of Turin, Italy	Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Compagnia di San Paolo, Regione Piemonte, Turin, Italy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)		6 months	No
Secondary	Analgesic drug consumption after 6 and 12 months		12 months	No
Secondary	Headache index after 6 and 12 months		12 months	No
Secondary	Neck and shoulder pain index after 6 and 12 months		12 months	No
Secondary	Muscle tenderness at palpation after 6 and 12 months		12 months	No
Secondary	Psychiatric comorbidity and psychosomatic symptoms prevalence		12 months	No
Secondary	Frequency of pain in head/neck area after 12 months in both groups		12 months	No