Tactile acuity training for patients with chronic low back pain

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN98118082
• Date of registration: 06/02/2012
• Prospective Registration: No
• Primary sponsor: James Cook University Hospital (UK)
• Public title: Tactile acuity training for patients with chronic low back pain
• Scientific title: Tactile acuity training for patients with chronic low back pain: A pilot randomised controlled trial
• Date of first enrolment: 01/02/2012
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN98118082
• Study type: Interventional
• Study design: Pilot randomised controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Nicholas Harland

Key inclusion & exclusion criteria

Inclusion criteria: 1. More than 18 years of age
2. Pain duration of more than 6 months
3. Non-specific low back pain with or without leg pain
4. No red flags indicating potential serious pathology
5. No clinical signs of peripheral neuropathy such as:
5.1. Reduced muscle power
5.2. Loss of sensation or loss of reflex
Exclusion criteria: 1. Not having an informal carer (friend/relative) willing to facilitate with the home program
2. Being unable to write/speak English
3. Have learning difficulties or are not capable of giving consent

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic low back pain
Musculoskeletal Diseases
Low back pain

Intervention(s)

Tactile acuity training in the lower back region versus Sham Tactile Acuity (palcebo/control)

Placebo (control group)
The placebo intervention will be delivered on three occasions in the physiotherapy department by the Physiotherapist and daily at home by an informal carer (friend/relative) as part of the home training package over the course of treatment. The training takes 30 minutes. There are two components to the placebo intervention.

1. Tactile stimulation:
Will involve marking 8 number dots on the back area in most pain with a hypoallergenic pen specifically designed for skin use. These sites will be separated by the distance of the predetermined two point discrimination ability. The sites are then stimulated in a random order using either a big (wine bottle cork) or small (pen top) probe, again randomly applied. The interstimulus interval is 15 seconds. Three 6 minute blocks of 24 stimuli are performed with 3 minutes rest between blocks in accordance with previous protocols. The participant does not interact with the stimulus. Instead they engage in some other activity e.g. read a book or watch TV. The tactile stimulation session is performed daily and each session should provide 72 stimuli over 24 minutes.

2. Back writing:
The area of most pain will have letters, approximately 1 inch high traced onto it. The researcher/informal carer will trace a series of 60 letters with the tip of their finger. Again no interaction with the patient will occur. This should take approximately five minutes.

Intervention group
The intervention will be delivered on three occasions in the physiotherapy department by the Physiotherapist and daily at home by the informal carer as part of the home training package over the course of treatment. The training takes 30 minutes. There are two components to the intervention.

1. Tactile acuity training:
Will involve marking 5-8 numbered dots on the back area in most pain. These sites will be separated by the distance of the pred

Primary Outcome(s)

1. Pain (Numerical Rating Scale)
2. Function (Roland Morris Disability Questionnaire)

Secondary Outcome(s)

Qualitative feedback about the intervention via interviews & focus groups

Secondary ID(s)

11/NE/0328

Source(s) of Monetary Support

University Research Fund (URF), Teesside University (UK)