No effect of traction in patients with low back pain: a single centre, single blind, randomized controlled trial of Intervertebral Differential Dynamics Therapy

Abstract

Low back pain (LBP) poses a significant problem to society. Although initial conservative therapy may be beneficial, persisting chronic LBP still frequently leads to expensive invasive intervention. A novel non-invasive therapy that focuses on discogenic LBP is Intervertebral Differential Dynamics Therapy (IDD Therapy, North American Medical Corp. Reg U.S.). IDD Therapy consists of intermittent traction sessions in the Accu-SPINA device (Steadfast Corporation Ltd, Essex, UK), an FDA approved, class II medical device. The intervertebral disc and facet joints are unloaded through axial distraction, positioning and relaxation cycles. The purpose of this study is to investigate the effect of IDD Therapy when added to a standard graded activity program for chronic LBP patients. In a single blind, single centre, randomized controlled trial; 60 consecutive patients were assigned to either the SHAM or the IDD Therapy. All subjects received the standard conservative therapeutic care (graded activity) and 20 sessions in the Accu-SPINA device. The traction weight in the IDD Therapy was systematically increased until 50% of a person's body weight plus 4.45 kg (10 lb) was reached. The SHAM group received a non-therapeutic traction weight of 4.45 kg in all sessions. The main outcome was assessed using a 100-mm visual analogue scale (VAS) for LBP. Secondary outcomes were VAS scores for leg pain, Oswestry Disability Index (ODI), Short-Form 36 (SF-36). All parameters were measured before and 2, 6 and 14 weeks after start of the treatment. Fear of (re)injury due to movement or activities (Tampa Scale for Kinesiophobia), coping strategies (Utrecht Coping List) and use of pain medication were recorded before and at 14 weeks. A repeated measures analysis was performed. The two groups were comparable at baseline in terms of demographic, clinical and psychological characteristics, indicating that the random allocation had succeeded. VAS low back pain improved significantly from 61 (+/-25) to 32 (+/-27) with the IDD protocol and 53 (+/-26) to 36 (+/-27) in the SHAM protocol. Moreover, leg pain, ODI and SF-36 scores improved significantly but in both groups. The use of pain medication decreased significantly, whereas scores for kinesiophobia and coping remained at the same non-pathological level. None of the parameters showed a difference between both protocols. Both treatment regimes had a significant beneficial effect on LBP, leg pain, functional status and quality of life after 14 weeks. The added axial, intermittent, mechanical traction of IDD Therapy to a standard graded activity program has been shown not to be effective.

Fig. 1

Time line of the treatment protocol. The treatment started with the traction therapy whether the IDD or the SHAM protocol. This consisted of 20 half-hour sessions during the first 6 weeks of the treatment (green line). Two weeks after initiation started the standard therapeutic care (graded activity) and lasted 12 weeks (blue line). The graded activity program consisted of 1 h of training for 2 days per week

Fig. 2

Mean VAS scores (±SD) of low back pain in the IDD group and the SHAM group. The effect of time was statistically significant (P < 0.05)

Fig. 3

Functional status, as measured with the ODI, in the IDD group and the SHAM group. The effect of time was statistically significant (P < 0.05)

Fig. 4

Health-related quality of life, as measured with the SF-36, in the IDD group and the SHAM group. Only the effect of time was statistically significant (P < 0.05), indicating an improvement after 14 weeks regardless of traction protocol