Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001110370
Ethics application status
Approved
Date submitted
24/07/2017
Date registered
28/07/2017
Date last updated
10/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The short term effects of Gravity Relief Mobilisation massage therapy on chronic low back pain.
Scientific title
Effects of Gravity Relief Mobilisation on Chronic Low Back Pain: a series of single-case experiments.
Secondary ID [1] 292399 0
None
Universal Trial Number (UTN)
U1111-1199-0826
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 303982 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303325 303325 0 0
Other physical medicine / rehabilitation
Musculoskeletal 303496 303496 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (phase 'B') involves attendance to a series of treatment sessions over 12 weeks and no further treatments over a follow up sub-phase of 12 weeks. The follow up period cannot be considered a seperate withdrawal phase because potential carry over effects are not expected to return to base line levels immediately after ceasing treatments.

The treatment sessions consist of a massage therapy based clinical intervention that a utilises a process approach to rehabilitation (Lederman, 2015). The intervention is comprised of both manual therapy and educational components that address the musculoskeletal system. The main activity is a novel form of myofascial release type indirect manual therapy that we have called Gravity Relief mobilisation (GRM).

GRM induces muscle contraction and relaxation to gently mobilise tissues and joints. This is achieved indirectly by the amelioration of gravity, activating the mobilisation of nerves, muscles, connective tissues, and joints. The mechanism at work induces reflex like non-volitional motor activity. Coupled to the amelioration of gravity are holding techniques and angular cross stretches that are applied with the hands gently to the soft tissues .

Preceding application of GRM, gliding and kneading massage techniques are used to induce a feel-good relaxation effect. During the treatment if appropriate breathing mechanics are discussed and practiced at the time thoracic and cervical regions are being addressed. The treatment sessions will conclude with exercise and stretching advice and salient postural problems are attended to with education about good standing posture and how this may be achieved. In addition, movement education of basic movements is incorporated, if indicated by pain or difficulty with daily activities. Follow up advice to practice the exercises at home is given to consolidate treatment session gains.

The interventions manual therapy components are applied with the participant lying comfortably on a massage table, they may be undressed down to their underwear for massage contact with the skin. The table is adjusted for tilt and bolsters are used for maximal comfort.

Participants will be draped at all times with only the body region being worked on exposed, buttocks and chest areas will remain covered at all times. The participant may choose to receive the treatment fully dressed wearing light flexible clothing. Participant comfort and sense of security is prioritised.

The intervention consists of a minimum of four and maximum of 12 treatment sessions delivered over the course of 12 weeks. The treatment sessions will be booked a maximum of three weeks apart and a minimum of one week apart. This will be negotiated between the participant and the therapists recommendations, reflecting clinical practice procedures.

An increase in pain lasting for 24-72 hours, is sometimes observed after a treatment session, therefore follow ups are scheduled according to the response and recovery from previous treatments. This ensures that any adverse effects will not interfere with important roles and responsibilities of the participant.

Each treatment session is between 1 - 1 1/2 hours duration. The length of the session is influenced by client tolerance for lying on the table. Treatment times for participants who have allodynia or experience distress in static positions will be titrated. Sessions will start at no longer than 60 minutes including assessment. If the response and recovery is acceptable to the client the next session time will be increased by 15 minutes until the 90 minute maximum is reached.

The intervention has been developed and will be delivered by a qualified and Massage New Zealand (MNZ) Level 7 registered massage therapist with 12 years clinical practice experience.

All treatment sessions are being video recorded and a random selection viewed for the purpose of assessing fidelity. Observer XT software will be used to code the practitioners observable behaviours, and the resulting data assessed against a list of required behaviours. The required behaviours correspond to a detailed treatment manual and are bound by minimum and maximum durations.

Intervention fidelity is being assessed by another MNZ Level 7 registered massage therapist who holds a Masters Degree in Health Science and works as a research fellow. This therapist is the treatment manuals co-author and will be trained in the novel GRM technique before the participants cross over to the intervention phase. As the therapist conducting the fidelity assessment is already highly qualified in massage and rehabilitation studies, only GRM training is needed.

Training will consist of demonstration of GRM techniques on a volunteer by the interventions developer, following the techniques as they are outlined in "Chronic Low Back Pain Treatment manual V1.0 Characterisation of a Novel Intervention"(Verhagen and Brown, 2017).

The treatment manual describes in detail how GRM is applied to each of the body regions. The regions are specified as: head (cephalic), neck (cervical), back (dorsal- below neck to below waist not including shoulders), ribs or thoracic (trunk), pelvis, shoulders-arms-hands (upper extremity), hips-knees-feet and ankles (lower extremity). The abdomen is not targeted in this intervention.

The GRM training will consist of an hour demonstration and an hour of practice.
Intervention code [1] 298576 0
Rehabilitation
Intervention code [2] 298711 0
Treatment: Other
Comparator / control treatment
Each single case-experiment has a control phase 'A', to establish the baseline level and stability of participants low back pain with repeated measurements.

Each control (phase 'A'), consists of randomised baseline length of 3,4,5,6 or 7 weeks. During baseline measurement the participant will be required to complete an online pain assessment survey called the PainQuILT 3x/week on specified days and at a time chosen by them. They will log onto the survey tool with an anonymised email address allocated to them which is password protected. The PainQuILT takes approximately 5 minutes to complete.

At time of enrolment participants will be trained how to use the PainQuILT tool following the PainQuILT Demonstration Guide provided by the tools licensors, Mc Masters University.
Control group
Active

Outcomes
Primary outcome [1] 302787 0
A change in the PainQuILT survey mean pain intensity score.

Possible adverse effects after treatment session delivery of increase in mean pain intensity is also being monitored with the PainQuILT survey.
Timepoint [1] 302787 0
Participant outcomes will be measured repeatedly by ecological momentary assessments (EMA).
Phase 'A':
*3x per week for duration of the baseline period (3-7 weeks)
Phase 'B':
* 1x per week on a day specified by the participant.
*immediately before and after treatment sessions and,
*3 days consecutively after their treatment sessions.

Each EMA is to completed at the same time of day +/- 1 hour, If a day is missed it may be completed on the following day at the same time.
Primary outcome [2] 302789 0
A change in the PainQuILT survey number of painful sites.

Possible adverse effects after treatment session delivery of increase in number of painful sites is also being monitored with the PainQuILT survey.
Timepoint [2] 302789 0
Participant outcomes will be measured repeatedly by EMA.
Phase 'A':
*3x per week for duration of the baseline period (3-7 weeks)
Phase 'B':
* 1x per week on a day specified by the participant.
*immediately before and after treatment sessions and,
*3 days consecutively after their treatment sessions.

Each EMA is to completed at the same time of day +/- 1 hour, If a day is missed it may be completed on the following day at the same time.
Primary outcome [3] 302842 0
A change in the PainQuILT survey pain interference score.

Possible adverse effects after treatment session delivery of increase pain interference score is also being monitored with the PainQuILT survey.
Timepoint [3] 302842 0
Participant outcomes will be measured repeatedly by EMA.
Phase 'A':
*3x per week for duration of the baseline period (3-7 weeks)
Phase 'B':
* 1x per week on a day specified by the participant.
*immediately before and after treatment sessions and,
*3 days consecutively after their treatment sessions.

Each EMA is to completed at the same time of day +/- 1 hour, If a day is missed it may be completed on the following day at the same time.
Secondary outcome [1] 337241 0
A change in the PainQuILT survey mean pain intensity score.
Timepoint [1] 337241 0
EMA during follow up sub-phase: * 3x/week every fourth week for 12 weeks on days specified by the participant. Each EMA is to completed at the same time of day +/- 1 hour, If a day is missed it may be completed on the following day at the same time.
Secondary outcome [2] 337242 0
A change in the PainQuILT survey number of painful sites.
Timepoint [2] 337242 0
EMA during follow up sub-phase: * 3x/week every fourth week for 12 weeks on days specified by the participant. Each EMA is to completed at the same time of day +/- 1 hour, If a day is missed it may be completed on the following day at the same time.
Secondary outcome [3] 337243 0
A change in the PainQuILT survey pain interference score.
Timepoint [3] 337243 0
EMA during follow up sub-phase: * 3x/week every fourth week for 12 weeks on days specified by the participant. Each EMA is to completed at the same time of day +/- 1 hour, If a day is missed it may be completed on the following day at the same time.
Secondary outcome [4] 337244 0
PainQuILT User Acceptability e-scale
Timepoint [4] 337244 0
After the completion of the 12 week follow up sub-phase.

Eligibility
Key inclusion criteria
*self-reported low back pain located on the posterior of the body from the inferior margin of the 12th rib to the gluteal folds
*low back pain for 6 months or longer and
*low back pain experienced at least half of the days of the past 6 months
*non-responsive to usual care (as per ACC Acute Low Back Pain Guide) and over-the-counter pain relief.






Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*receiving treatment for low back pain (other than over-the-counter pain relief)
*underlying medical condition contraindicating massage therapy
*body mass index (Weight/Height²) greater than 40kg/m2
*currently under care of a clinical psychologist or psychiatrist
*pregnancy or delivered birth in the last 12 months
*scheduled to begin a new treatment for pain relief either naturopathic or allopathic or other medical intervention within study period
*substance abuse and addictions
*unable to use an electronic device with internet or mobile access

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This study contains five across-subject replications of a single-case experiment using a bi-phasic A-B design. Phase A is the control phase and phase B is the intervention phase.

Phase B consists of a treatment period (12 weeks) and a follow-up sub-phase (12 weeks). The treatment period includes additional sub phases after treatment sessions (3 consecutive days). The phases are determined a priori.

An intermediary person will screen potential participants for eligibility and participants are blinded to baseline length until after completing the enrollment process.

Each participant will be allocated a random baseline length between 3-7 weeks duration. The baseline allocation schedule is being held off site consisting of a simple sequence of computer generated random whole numbers.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis: for each individual subject, each outcome variable (mean pain intensity, number of painful sites and pain interference score) will be assessed longitudinally using visual analysis, SCED specific d-statistic comparing the mean of baseline measures with the mean of the treatment phase measures (Hedges, Pustejovsky, & Shadish, 2012), mean phase difference (MPD) and slope and level change (SLC) using the R code provided by Manolov and meta-analysis of the MPD and SLC. The MPD and SLC allow for an analysis of data adjusting for unstable baseline trends. The SCED specific d-statistic incorporates between-individual differences as well as within-individual differences. The meta-analysis of MPD and SLC provides a convenient way of summarising the data across all studied subjects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2017
Actual
4/08/2017
Date of last participant enrolment
Anticipated
4/09/2017
Actual
5/09/2017
Date of last data collection
Anticipated
4/05/2018
Actual
4/05/2018
Sample size
Target
5
Accrual to date
Final
5
Recruitment outside Australia
Country [1] 9063 0
New Zealand
State/province [1] 9063 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 296951 0
University
Name [1] 296951 0
University of Otago
Country [1] 296951 0
New Zealand
Funding source category [2] 297100 0
Self funded/Unfunded
Name [2] 297100 0
Heidi H Verhagen
Country [2] 297100 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Medicine,
University of Otago Wellington,
23a Mein St,
Newtown,
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 296109 0
None
Name [1] 296109 0
Address [1] 296109 0
Country [1] 296109 0
Other collaborator category [1] 279658 0
Individual
Name [1] 279658 0
Melanie Brown
Address [1] 279658 0
Rehabilitation Teaching and Research Unit
University of Otago Wellington
23a Mein St,
Newtown,
Wellington 6021.
Country [1] 279658 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298156 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 298156 0
Ethics committee country [1] 298156 0
New Zealand
Date submitted for ethics approval [1] 298156 0
14/07/2017
Approval date [1] 298156 0
21/07/2017
Ethics approval number [1] 298156 0
H17/063

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76170 0
Dr Rebecca Grainger
Address 76170 0
Department of Medicine,
University of Otago Wellington,
23a Mein St,
Newtown,
Wellington 6021.
Country 76170 0
New Zealand
Phone 76170 0
+64 4 806 1031
Fax 76170 0
Email 76170 0
[email protected]
Contact person for public queries
Name 76171 0
Heidi Verhagen
Address 76171 0
T/A Forte Body Reconditioning,
PO Box 12037,
Rotorua South,
Rotorua 3045.
Country 76171 0
New Zealand
Phone 76171 0
+64 7 350 3373
Fax 76171 0
Email 76171 0
[email protected]
Contact person for scientific queries
Name 76172 0
Heidi Verhagen
Address 76172 0
T/A Forte Body Reconditioning,
PO Box 12037,
Rotorua South,
Rotorua 3045.
Country 76172 0
New Zealand
Phone 76172 0
+6473503373
Fax 76172 0
Email 76172 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.