Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain

NCT01981798 | Completed DMC

• 1 other identifier: Praev123
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

To investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on chronic unspecific back or neck pain. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.

Conditions

Chronic Low Back Pain; Neck Pain

Keywords

outpatient intervention program; behavioral therapy approach; unspecific back pain; unspecific neck pain; chronic pain; physiotherapy; occupational therapy; psychosocial aspects; fear avoidance beliefs; health-related quality of life

Outcome Measures

Primary Outcomes (1)

• Pain

  To evaluate the main hypothesis, current pain and mean pain during the preceding week and the preceding 3 months were determined on a visual analog scale (VAS; 0-100, lower scores indicate less severe pain)

  After 0 / 6 / 58 Weeks

Secondary Outcomes (6)

• Social function, psychological wellbeing and emotional role function

  After 0 / 6 / 58 weeks

• Functional impairment

  After 0 / 6 / 58 weeks

• Anxiety, insecurity in social contacts and compulsiveness

  After 0 / 6 / 58 weeks

• Sick leave days

  After 0 / 58 weeks

• Painkillers

  After 0 / 58 weeks

Study Arms (2)

Training group

ACTIVE COMPARATOR

Physiotherapy and occupational therapy: Training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour.

Behavioral: Physiotherapy and occupational therapy

Control Group

NO INTERVENTION

Members of the control group were referred to their general practitioner or specialist for further care.

Interventions

Physiotherapy and occupational therapy BEHAVIORAL

Members of the training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour. Every patient of the IG was trained to perform a neck or back intervention program specifically suited to his/her needs. The training was conducted in a single session by one of three experienced physiotherapists (with mean work experience of 6 years). After this training the patients completed eight group training units consisting a maximum number of 8 participants, each unit with a duration of one hour, over a maximum period of six weeks.

Training group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• minimum age 18 years, maximum age: men 55 years, women 50 years.
• the patients had been on sick leave for a minimum of 4 and a maximum of 22 days during the preceding 12 months because of nonspecific spinal symptoms in the back or neck.
• The patients had to be working at the start of the study.

You may not qualify if:

• Specific causes of spinal symptoms (after spinal surgery, known vertebral body fractures, disk prolapse with motor deficits or other radicular lesions, tumor, osteomyelitis, spondylodiscitis, rheumatic disease, osteoporosis).
• Retired persons, those in the process of being screened for retirement, unemployed persons,
• pregnancy or persons on maternity leave
• Planned surgery during the phase of intervention
• persons who were unable to participate in the intervention program for other reasons (physical, psychological, linguistic or organizational).

Sponsors & Collaborators

• Orthopedic Hospital Vienna Speising: lead

Study Sites (1)

Orthopedic Hospital Vienna Speising

Vienna, Vienna, 1130, Austria

Location

Related Publications (10)

• Chou R, Loeser JD, Owens DK, Rosenquist RW, Atlas SJ, Baisden J, Carragee EJ, Grabois M, Murphy DR, Resnick DK, Stanos SP, Shaffer WO, Wall EM; American Pain Society Low Back Pain Guideline Panel. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976). 2009 May 1;34(10):1066-77. doi: 10.1097/BRS.0b013e3181a1390d.

  PMID: 19363457 BACKGROUND

• Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.

  PMID: 16550448 BACKGROUND

• Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.

  PMID: 8455963 BACKGROUND

• Klenerman L, Slade PD, Stanley IM, Pennie B, Reilly JP, Atchison LE, Troup JD, Rose MJ. The prediction of chronicity in patients with an acute attack of low back pain in a general practice setting. Spine (Phila Pa 1976). 1995 Feb 15;20(4):478-84. doi: 10.1097/00007632-199502001-00012.

  PMID: 7747233 BACKGROUND

• van Middelkoop M, Rubinstein SM, Kuijpers T, Verhagen AP, Ostelo R, Koes BW, van Tulder MW. A systematic review on the effectiveness of physical and rehabilitation interventions for chronic non-specific low back pain. Eur Spine J. 2011 Jan;20(1):19-39. doi: 10.1007/s00586-010-1518-3. Epub 2010 Jul 18.

  PMID: 20640863 BACKGROUND

• Somerville S, Hay E, Lewis M, Barber J, van der Windt D, Hill J, Sowden G. Content and outcome of usual primary care for back pain: a systematic review. Br J Gen Pract. 2008 Nov;58(556):790-7, i-vi. doi: 10.3399/bjgp08X319909.

  PMID: 19000402 BACKGROUND

• Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine (Phila Pa 1976). 1999 Dec 1;24(23):2484-91. doi: 10.1097/00007632-199912010-00010.

  PMID: 10626311 BACKGROUND

• Hides JA, Jull GA, Richardson CA. Long-term effects of specific stabilizing exercises for first-episode low back pain. Spine (Phila Pa 1976). 2001 Jun 1;26(11):E243-8. doi: 10.1097/00007632-200106010-00004.

  PMID: 11389408 BACKGROUND

• Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR; Back Skills Training Trial investigators. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010 Mar 13;375(9718):916-23. doi: 10.1016/S0140-6736(09)62164-4. Epub 2010 Feb 25.

  PMID: 20189241 BACKGROUND

• Johnson RE, Jones GT, Wiles NJ, Chaddock C, Potter RG, Roberts C, Symmons DP, Watson PJ, Torgerson DJ, Macfarlane GJ. Active exercise, education, and cognitive behavioral therapy for persistent disabling low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2007 Jul 1;32(15):1578-85. doi: 10.1097/BRS.0b013e318074f890.

  PMID: 17621203 BACKGROUND

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Interventions

Physical Therapy Modalities; Occupational Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Florian Wepner, Dr.

  Orthopedic Hospital Vienna Speising

  PRINCIPAL INVESTIGATOR

• Martin Friedrich, Prof.

  Orthopedic Hospital Vienna Speising

  STUDY CHAIR

• Julia Hahne, Mag.

  Orthopedic Hospital Vienna Speising

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: November 13, 2013
• Study Start: March 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

AU (1)