Back pain - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

University of Oxford

Recruitment countries:

United Kingdom

Health condition studied:

Back Ache

URL:

Link to the clinical trial website

About the trial

Interventions:

Device: ActiPatch (active)
Device: ActiPatch (placebo)

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  - Participant is willing and able to give informed consent for participation in the
  trial.
  
  - In the Investigator's opinion, is able and willing to comply with all trial
  requirements.
  
  - Willing to allow his or her General Practitioner and consultant, if appropriate, to
  be notified of participation in the trial.
  
  - Male or female ages 18-90 years old with stable chronic low back pain
  
  - =3 months duration of chronic low back pain
  
  - a current VAS pain rating =5/10
  
  - no radiating pain below the knee
  
  - =75% back or buttock pain rather than lower extremity pain
  
  - Able to complete and tolerate treatment for the study period.
  
  Exclusion Criteria:
  
  - Female participant who is pregnant
  
  - Significant renal or hepatic impairment.
  
  - Prior home use of pulsed shortwave therapy
  
  - Prior history of spinal fusion or failed spinal surgery syndrome.
  
  - Laminectomy, laminotomy or discectomy within 12 months of enrollment.
  
  - Diagnostic or interventional injections or any low back surgeries not mentioned
  above, including radiofrequency neuroablation within 6 months of enrollment.
  
  - Any addition of strong opiates, pregabalin and gabapentin to the treatment regime
  during the course of the trial
  
  - Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, spinal
  stimulators or other implanted electronic devices.
  
  - Patients using personal home based electrical stimulation devices
  
  - Patients with other concomitant illnesses (e.g., malignancy, osteoporosis) which, in
  the opinion of the investigator, would preclude successful patient participation will
  also be excluded
  
  - Active psychiatric disorders (as evidenced by use of antipsychotic or medication).
  
  - Patients diagnosed with history of significant mood disorder will be excluded
  (depression or anxiety with adequate control would be acceptable).
  
  - Scheduled elective surgery or other procedures requiring general anaesthesia during
  the trial.
  
  - Participant with life expectancy of less than 6 months, or inappropriate for placebo
  medication.
  
  - Any other significant disease or disorder which, in the opinion of the Investigator,
  may either put the participants at risk because of participation in the trial, or may
  influence the result of the trial, or the participant's ability to participate in the
  trial.
  
  - Participants who have participated in another research trial involving an
  investigational product in the past 12 weeks.
  
  - Participants who are not able to understand verbal or written English, and for whom
  adequate translation/interpretation cannot be readily obtained.
  

• Age minimum: 18 Years
• Age maximum: 90 Years
• Gender: Both

Primary outcomes:

Pain-related disability, indexed by the Oswestry Disability Index (ODI)

Secondary outcomes:

Medication intake
Pain related disability, indexed by the Roland Morris Instrument
Quality of life, indexed by the EQ-5D-5L questionnaire
Subjective pain, indexed by Visual analogue pain scale

Target sample size:

30

Study type:

Interventional

Study design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Contacts:

• Name: Tipu Z Aziz
• Address:
• Phone: 01865231885
• Email: tipu.aziz@nds.ox.ac.uk
• Affiliation:

• Name: Tipu Z Aziz
• Address:
• Phone: 01865231885
• Email: tipu.aziz@nds.ox.ac.uk
• Affiliation:

Technical details

Scientific title:

A Randomised Controlled Trial to Assess the Benefits of ActiPatch-Pulsed Shortwave Therapy for Chronic Lower Back Pain

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT02601807

Secondary ID:

15/LO/0926

Register:

ClinicalTrials.gov

Date of registration:

21/10/2024

Date of first enrollment:

August 2015

Last refreshed:

23 May 2024