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Table 1 Characteristics of IHC Controlled Clinical Trials

From: Process of care in outpatient Integrative healthcare facilities: a systematic review of clinical trials

Author, Ref

Sample, Diagnosis & Setting (Trial design)

IHC Intervention (Duration)/ Comparator

Outcomes measured

Results

Westrom et al. 2010; Maiers et al. 2010; Bronfort et al. 2012; Westrom et al. 2010 [39, 41, 44, 89]

201 adults with LBP ≥ 6 weeks (RCT).

Integrative, multidisciplinary care: acupuncture, oriental medicine, cognitive behavior therapy, exercise, massage, chiropractic and/or medicine (12 weeks)

Patient Self-Assessment Form (PSAF is a modified form of MYMOP); Frequency of symptoms; RMQD modified; Fear avoidance beliefs questionnaire; Pain Self Efficacy Questionnaire; EuroQol 5D, improvement pm a 9 point ordinal scale, satisfaction, work loss, and medication use; also Lumbar dynamic motion and Torso muscle endurance. Semi-structured interviews with both patients and providers at the end of the study.

IHC group statistically significant improvement in pain reduction, perceived global improvement and satisfaction with care.

 

Vs

  

Setting: Wolfe Harris Centre for Clinical Studies, Northwestern Health Sciences University, Minnesota, USA

Chiropractic care alone.

Assessed: wks 12, 52

 

Eisenberg et al. 2012 [38]

20 adults with LBP for 3–12 weeks in the US (RCT, Pilot)

Integrative, individualized care: acupuncture, chiropractic, massage, occupational therapy, physical therapy, mind-body techniques, neurology consultation, nutritional counselling, orthopaedics consultation, and psychiatry and rheumatology consultation and referrals as appropriate, plus usual care (12 weeks). Treatment provided up to two times per week, with up to two treatment modalities per session.

RMQD; Symptom relief using Bothersome index past 24 h; Pain past 24 h; SF12; Worry

Week 12 Roland Morris (p < 0.08); bothersome (p < 0.02); pain (0.005)

Setting: multi-speciality group practice, and an academic teaching hospital (Outpatients), Boston, USA

PLUS Usual Care

Assessed: wks 2, 5, 12, 26.

Preliminary findings: significant difference in favour of the IHC group on pain reduction, perceived global improvement at 12 and 26 weeks.

 

Vs

  
 

Usual care alone including medications, referral for physical therapy as needed, education, limited bed rest and activity alterations

  

Goertz et al. 2013 [37]

120 sub-acute or chronic LBP of at least 4 weeks duration in adults ≥ 65 years (RCT, Pilot).

Collaborative medical, osteopathic and chiropractic care who comprise a patient-centred, co-management team (up to 12 weeks)

Primary outcome self-report LBP on a 11-point numerical rating scale (NRS); RMQD; SF36 (Veterans RAND); FABQ; Functional mobility with Timed Up and Go test; symptom bothersomeness index past week; depression and anxiety (Patient Health Questionnaire-9 for depression; General Anxiety Disorder −7); Self-report healthcare utilisation, expenditure and medication use; Questionnaire to assess expectations, improvement, satisfaction; Specific process outcomes: participant and provider perceptions of the collaborative care model and the clinical trial design.

Protocol only, trial underway. This is a pilot to assess and refine the collaborative care model and the sample size has not been calculated to detect a significant difference on the outcome measures.

Setting: Chiropractic research clinic and Family Medical Centre, USA

VS

  
 

concurrent medical and chiropractic care provided by an unlinked family medicine physician and a doctor of chiropractic

Assessed: Baseline, 4, 8 and 12 weeks (primary endpoint), and every 12 weeks after up to one year.

 
 

VS

  
 

conventional medical care provided by a family medicine physician

  

Sundberg et al. 2009; Sundberg et al. 2007 [36, 46]

80 adults with back/neck pain of at least 2 weeks duration (RCT).

IHC involving an individualized treatment plan provided by a multidisciplinary IM team coordinated by a gate keeping GP. Therapies included seven sessions of a selection of the following: massage, manipulative therapy, shiatsu, acupuncture, qigong (group based) for a period over 10 weeks.

SF36; IM tailored outcomes targeting self-rated disability, stress and well-being; Days in pain (0–14); Healthcare utilisation and medication use. Focus group discussions exploring participants’ experiences and perceptions of conventional and integrative care.

Significant improvement in one (vitality) of the eight domains of the SF-36. Trend to less medication use in the IHC group. Underpowered.

Setting: IM clinic operating 5 days per week at a primary care unit in Sweden 2003-2006

PLUS Usual Care

Assessed: Baseline, 12 weeks, 16 weeks (by post)

 

VS

  

Usual care

  

Richardson et al. 2001a; Richardson et al. 2001b [35, 40]

330 adults with over 20 conditions (quasi-experimental).

Integrative, multidisciplinary, individualized care: Acupuncture, Homeopathy, and Osteopathy for six treatment sessions up to 12 weeks.

SF36 baseline and at completion of treatment. Patients were asked about their satisfaction and experience of the service.

Significant improvements in the intervention group in seven of the SF36 eight domains.

 

VS

  

Setting: Complementary Therapy Centre set up within a hospital, UK

Waitlist

  
  1. RMQD Roland Morris Disability Questionnaire, SF12 and SF36 the Short Form (12 or 36) Health Survey, FABQ Fear Avoidance Beliefs Questionnaire